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FDA Warning Letter Explorer
Medical Devices · Letter issue date: Aug 26, 2026

Peter Schiff Enterprises

8 extracted findings

FDA source excerpt, selected passage

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,

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Findings extracted from the letter

Selected FDA passages, not the complete letter.

01
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,
02
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).
03
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:
04
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,
05
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,
06
Failure to adequately establish procedures for quality audits, as required by 21 CFR 820.22.
07
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.
08
Failure to adequately maintain a device history record, as required by 21 CFR 820.184. For example,

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 83021 CFR 82021 CFR 890.117521 CFR 807.81(a)21 CFR 807.81(a)(3)21 CFR 807.81(b)21 CFR 820.5021 CFR 820.30(a)21 CFR 820.198(a)21 CFR 820.3(b)21 CFR 820.100(a)21 CFR 820.90(a)21 CFR 820.80(d)21 CFR 820.2221 CFR 820.20(c)21 CFR 820.18421 CFR 803.1721 CFR 801.20(a)21 CFR 801.321 CFR 801.40(a)(1)21 CFR 801.40(a)(2)21 CFR 830.300(a)21 CFR 830.321 CFR 80321 CFR 801

For background, see Premarket notification (510(k)). Explore Botable’s work in Medical devices and Quality and regulatory operations.

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