Peter Schiff Enterprises

WARNING LETTER
CMS # 727888

August 26, 2026

Dear Mr. Schiff,

During an inspection of your firm located in Cookeville, TN from December 29, 2025, through December 31, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and markets cardiac electrode pads (Models 305L and 306L) and AC cardiac fibrillators (Model 310C). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are, among other things, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, and they do not achieve their primary intended purposes through chemical action within or on the body of man or other animals and are not dependent upon being metabolized for the achievement of their primary intended purposes.

Unapproved Device Violation
Our inspection revealed that your Model 310C Fibrillator and Models 305L and 306L cardiac electrode pad devices are adulterated under section 501(f)(1) of the Act, 21 U.S.C. § 351(f)(1), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not timely notify the agency of its intent to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of the devices, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a). The introduction or delivery for introduction into interstate commerce, or causing thereof, of any device that is adulterated or misbranded is prohibited under section 301(a) of the Act, 21 U.S.C. § 331(a).

Your firm asserts that the Model 310C Fibrillator is an unclassified pre-amendments device and you have listed it under product code LIW. However, the FDA inspection found that the device has been significantly modified since its introduction in 1966 into interstate commerce. Modifications include changes to the battery type and housing, changing from an analog system to a digital platform, increase of the voltage output specifications, and change in electrode placement. As described at page 10 of the FDA guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device”, “[m]anufacturers should conduct a risk-based assessment that compares the changed device to...their preamendments device...When the cumulative effect of individual changes triggers the regulatory threshold for submission, the manufacturer should submit a new 510(k).” The preamendments device uses two replaceable Mallory RM12R mercury batteries, a variable 0-7 volt output, and electrodes that are intended to be positioned under the ventricles. In contrast, the current version of your device uses a nonreplaceable lithium battery, fixed 9 or 18 volt output, and electrode pads that are placed under the myocardium. The current version also features an automatic 30-minute shutoff which indicates that the device has been updated from analog to digital. Your firm’s introduction of these updates represents changes or modifications that could significantly affect the safety or effectiveness of your device. See 21 CFR 807.81(a)(3).

For example, the different battery, voltage output, pads placement, and update from analog to digital, cumulatively increase the risk of injury associated with use of the device, such as burns, irritation or inflammation, pain, fever, toxicity that leads to tissue damage and/or loss of organ function or failure, etc. The design of the device is significantly changed from the original preamendments device due to these modifications. The changes should be appropriately verified and/or validated in accordance with the Quality Management System Regulation (QMSR) (21 CFR part 820) to ensure adequate performance. Inadequate performance may result in serious patient harm such as delay in procedure or failure to induce ventricular fibrillation as intended during open heart surgery on vulnerable patients, including critically ill cardiac surgery patients and pediatric patients undergoing congenital heart defect repairs.

Your firm asserts that the Models 305L and 306L cardiac electrode pads fall within the scope of 21 CFR 890.1175 Electrode cable and are exempt from premarket notification. Generic devices of this type are typically composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine. However, the Models 305L and 306L cardiac electrode pads are intended to connect a fibrillator to cardiac tissue and do not have a diagnostic function. They are, therefore, not exempt from pre-market notification because they are not the type of device that is within the generic category of devices identified under 21 CFR 890.1175.

In order to allow FDA to formally determine the appropriate classification of your devices, FDA recommends submission of a 513(g) Request for Information to obtain a formal response from FDA. For instructions on how to submit a 513(g) Request, please refer to the following guidance document: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act | FDA.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that you need to submit in order to obtain approval or clearance authorization for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Quality System Regulation Violations
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System Regulation found at Title 21, CFR, part 820. We received responses from Peter Schiff, Owner, dated January 11, 2026 and June 16, 2026, concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. The violations found during the inspection include, but are not limited to, the following:

1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example,

a. On December 29, 2025, the Quality Control Manager stated that your firm does not have a purchasing control procedure that would evaluate and define the type and extent of control to be exercised over suppliers, and that you have no quality agreements with any of the suppliers on the Approved Supplier List (ASL) that would dictate the level of control that the company has over the supplier, including requirements for suppliers to notify your firm of any changes to the materials used in manufacturing the components.

Furthermore, according to the Quality Control Manager, supplier selection is performed by the owner of your firm without documented procedures or documentation of quality requirements used in the selection process. For example, your firm has not performed a qualification or evaluation of your supplier of stainless-steel electrode cups used in the manufacture of the adult and pediatric cardiac electrode pads.

b. The firm does not have documented specified requirements, including quality requirements, for materials used in the cardiac electrode pad manufacturing process, including but not limited to:

• (b)(4) that are purchased at local grocery/department stores and used during the cleaning process of the stainless-steel button on adult and pediatric electro pads. No specifications or quality requirements exist for these materials despite their direct contact with the finished medical device.

• (b)(4) purchased at local home improvement stores and used during the manufacturing process to clean the finished devices in a series of rinses in (b)(4) baths. No supplier qualification or acceptance criteria exist for this cleaning agent.

• Silicone materials used in the manufacturing of the cardiac electrode pads. The safety data sheets (SDS) mentioned the materials are “Not for internal or medical use” and “Industrial mold making. Not for internal or medical use.”

• (b)(4) material used in the manufacturing of the cardiac electrode pads. During the inspection, the Investigators observed (b)(4) containing (b)(4) during the walkthrough of the facility which is used in the preparation of the lead wires for the electrode pad production.

We reviewed your firm’s responses and conclude that they are not adequate. Your firm has not completed a biocompatibility assessment (i.e., biocompatibility testing or rationale for why biocompatibility testing is not necessary). An adequate biocompatibility assessment is important because patient or user exposure to your device could result in adverse health effects such as allergic reactions, skin irritation or inflammation, pain, fever, red blood cell damage that induces organ stress, and toxicity that leads to tissue damage and/or loss of organ function or failure. Specifically, FDA is concerned that the use of non-medical grade materials may result in increased levels of impurities as well as inconsistencies in the quality and safety of the materials used due to inadequate manufacturing controls. The use of non-medical grade materials and lack of biological testing may result in adverse health effects described above. Your firm should identify the tissue contacting components and materials of the device, including the chemical name, trade name, suppliers, dimensions/surface area (or amount if applicable), and whether the components have direct, indirect, or no contact with the patient’s circulating blood, tissue, and/or skin, as well as their expected duration of contact (e.g., transitory, limited, permanent, etc.). (See Section III Attachment F of FDA’s Biocompatibility Guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,’" (https://www.fda.gov/media/142959/download).) In addition, your firm should provide methods and results from biocompatibility testing of the subject device according to a recognized standard, and as recommended in Attachment A of FDA’s Biocompatibility Guidance for devices with the subject device’s nature and duration of tissue contact. The cardiac fibrillator device is an external communicating device that has either direct tissue contact or indirect circulating blood contact with the patient for less than 24 hours. In accordance with ISO 10993 part 1, for this type of product, CDRH recommends the following tests be considered: cytotoxicity, sensitization (guinea pig maximization with both polar and non-polar extracts), intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, and extract hemolysis (if indirect circulating blood contact).

2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm has not established design control procedures. Furthermore, your firm failed to follow Section 9 of the firm’s Quality Manual, effective 6/1/2020, which requires a Design History File for Adult Cardiac Electrode Pad (Model 305L), Pediatric Cardiac Electrode Pad (306L) and Cardiac Fibrillator (Model 310C).

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

3. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:

a. Your firm’s owner indicated that he receives “feedback” from customers involving the battery not starting on Cardiac Fibrillators manufactured by the firm. This “feedback” meets the definition of a complaint, as defined by 21 CFR 820.3(b), and was not documented as such.

b. Your firm maintains an uncontrolled document titled “Complaint Handling” that is used as the complaint handling procedure. This procedure lacks the definition of a complaint and it lacks requirements for:
1) Uniform and timely processing of complaints.

2) Evaluation of complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803 (Medical Device Reporting).

3) Evaluation of complaints to determine whether an investigation is necessary.

4) Ensuring any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

5) The elements that must be included in the record of investigation when an investigation is made including, but not limited to:
    (1) The name of the device.
    (2) The date the complaint was received.
    (3) Any unique device identifier (UDI) or universal product code (UPC) and any other device identification(s)/control number(s) used.
    (4) The name, address, and phone number of the complainant.
    (5) The nature and details of the complaint.
    (6) The dates and results of the investigation.
    (7) Any corrective action taken.
    (8) Any reply to the complainant.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

4. Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm failed to investigate the causes of nonconformities as well as document the corrective actions taken to address nonconformities. For example, your firm took the corrective action to address the 2017 FDA Observation 1 which consisted of using a contract sterilizer to perform sterilization validation for the Adult Electrode Pads (Model 305L) and Pediatric Electrode Pads (Model 306L). However, your firm failed to document the review of the validation sterilization report to verify that the corrective action taken was effective at validating the parameters listed within the instructions for use.

This is a repeat observation from the 2017, 2013, and 2011 FDA inspections.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

5. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example,

a. Your firm’s nonconformance procedure located within the Device History Records Procedures Manual, Doc #18-12/20/2025, fails to adequately establish how nonconforming product is documented, evaluated, and dispositioned. The procedure also lacks the requirement to determine the need for an investigation and notification of the persons or organizations responsible for the nonconformance. For example, production records for the cardiac electrode pads such as the following did not have a documented evaluation to determine the need for an investigation:

• Lot (b)(4) poured on (b)(4) resulting in 1 non-conforming unit with rust on the electrodes.

• Lot (b)(4) poured on (b)(4) resulting in 1 non-conforming unit with rust on the electrodes.

• Lot (b)(4) poured on (b)(4) resulting in 1 non-conforming unit with sunken electrodes and no QA release signature.

• Lot (b)(4) poured on (b)(4) resulting in 1 non-conforming unit with sunken electrodes.

• Lot (b)(4) poured on (b)(4) resulting in 1 non-conforming unit with unsecured wire.

• Lot (b)(4) poured on (b)(4) resulting in 1 non-conforming unit with unsecured wire and no QA release signature.

Furthermore, there is no documentation indicating that Adult Electrode Pads (Model 305L) and Pediatric Electrode Pads (Model 306L) rejected units have been reviewed and evaluated, or that disposition decisions have been made and approved by
authorized personnel. Production records only document the quantity produced and quantity accepted, with vague descriptors for rejected units.

b. Your firm’s Quality Control Manager indicated that wires from non-conforming Adult Electrode Pads (Model 305L) and Pediatric Electrode Pads (Model 306L) are routinely cut and reused in the production of new electrode pads, while the (b)(4) are discarded. This rework is not documented, and there is no evidence that the rework has been evaluated and approved, or that reworked product has been verified to meet specified requirements before being returned to production.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

6. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example,

a. Your firm released and distributed electrode pads from lot numbers (b)(4) manufactured between 11/3-12/5/2025 without the Quality Control Manager completing a final inspection of the product and label as required by procedure, Doc #18, Device History Records Procedures Manual, dated 12/20/2025.

b. The firm manufactured (b)(4) lots on (b)(4) and assigned them lot number (b)(4) despite your firm indicating that each lot number should be assigned a sequential number. The firm’s Quality Manager indicated she did not know what happened and did not know which product was distributed to the customer located in (b)(4) on (b)(4).

c. The firm has been releasing and distributing finished products with labeling showing an incorrect email for contacting the firm since March 2025.

This is a repeat observation from the 2013 FDA inspection.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

7. Failure to adequately establish procedures for quality audits, as required by 21 CFR 820.22.
For example,

a. Your firm’s document titled “Quality Manual”, Doc # 14, Effective 06/01/2020 states in section 15 that internal audits are to be conducted “periodically to verify compliance with the QMS and FDA requirements.” The Quality Control Manager stated during the
inspection on December 29, 2025, that no internal audits have been conducted by your firm and that the first audit is scheduled for January of 2026 despite your firm being in operation since 1966.

b. Your firm’s Quality Manual, which includes internal audit requirements fails to: establish a frequency for conducting internal audits; include auditing criteria; include the regulatory requirement that quality audits be conducted by individuals who do not have direct responsibility for the matters being audited; and the potential for reaudits if needed.

This is a repeat observation from the 2017, 2013, and 2011 FDA inspections.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

8. Failure to adequately establish procedures for management review, as required by 21 CFR 820.20(c). For example, the Quality Manual (Doc #14, dated 06/01/2020) describes in section 16 the criteria for conducting management reviews at planned intervals. Your firm has not performed management reviews despite the firm being in operation since 1966.

This is a repeat observation from the 2017, 2013, and 2011 FDA inspections.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

9. Failure to adequately maintain a device history record, as required by 21 CFR 820.184. For example,

a. The Device History Records (DHRs) do not include or refer to the location of the label and labeling used for each production run, lot, or batch of finished devices.

b. The DHRs do not include records of examination and release of device labeling, including the date and signature of the individual(s) performing the examination for production lots as evidenced by Cardiac Electrode Pad lots (b)(4), and (b)(4).

c. The DHR for Cardiac Electrode Pad lot (b)(4) was released by the Quality Control Manager, however manufacturing steps for continuity check after assembly, and subsequent cleaning and packaging activities were not documented as completed, which is required for release of finished product.

This is a repeat observation from the 2017 and 2011 FDA inspections.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

Medical Device Reporting (MDR) Violation

Our inspection also revealed that your firm failed to develop and maintain any written MDR procedures, as required by 21 CFR 803.17.

This is a repeat observation from the 2011 FDA inspection.

We reviewed your firm’s responses and conclude that they are not adequate. They do not address any FDA 483 observation corrective action plans or timeframes for coming into compliance.

The failure to establish or maintain any record, or make any report, required under section 519 of the Act, 21 U.S.C. § 360i, is prohibited under section 301(e) of the Act, 21 U.S.C. § 331(e).

Unique Device Identification (UDI) Violations
The inspection revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of the Act, specifically, under section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR part 801, subpart B, and 21 CFR part 830. The labels of the Pediatric (Model 306L) and Adult (Model 305L) cardiac electrode pad and AC cardiac fibrillator (Model 310C) devices do not bear such a UDI.

Specifically, the labels for the devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, there is no UDI presented in easily readable plain-text (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology (see 21 CFR 801.40(a)(2)). Your firm’s responses do not demonstrate that your devices have compliant labeling.

In addition, the Pediatric (Model 306L) and Adult (Model 305L) cardiac electrode pad and AC cardiac fibrillator (Model 310C) devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i and implementing regulations set forth in 21 CFR part 830, respecting these devices. In particular, 21 CFR 830.300(a) and 830.320(b), both of which were promulgated under section 519 of the Act, among other provisions, require, with exceptions not relevant here, that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR part 830, subpart E, for each version or model required to bear a UDI. Your firm is a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR part 830, subpart E, respecting these devices. The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

Based on our review of the Global Unique Device Identification Database (GUDID), there are no entries for your devices. Your responses do not address this concern.

On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspection, from December 29, 2025, through December 31, 2025, was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage:
Quality Management System Regulation – Frequently Asked Questions | FDA
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.

We are requesting that you submit to this office, on the schedule below, certification by an outside expert consultant that he or she has conducted an audit of your firm’s manufacturing and quality assurance systems relative to the requirements of the device Quality Management System Regulation (21 CFR part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your firm has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:

• Initial certifications by consultant and establishment – February 26, 2027

• Subsequent certifications – February 26, 2028 and February 26, 2029

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Melissa Michurski, Establishment Assessment Team 2, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 727888” when replying. If you have any questions about the contents of this letter, please contact: Ashley Mutawakkil, Compliance Officer, Ashley.Mutawakkil@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,

/S/
Barbara C. Marsden
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health