Med Pen Concepts, LLC: FDA Warning Letter (Sep 15, 2022)

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1
Failure to adequately establish and maintain procedures for the identification, documentation, validation, or (where appropriate) verification, review, and approval of design changes before their implementation, as required by 21 CFR § 820.30(i).

Passage 2
Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 CFR § 820.100(a). Specifically,

Passage 3
Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit as required by 21 CFR § 820.198.

Passage 4
Failure to adequately establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by 21 CFR § 820.80(b). Specifically,

Passage 5
Failure to maintain device history records (DHR's), as required by 21 CFR § 820.184.

Passage 6
Failure to adequately establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. The dates and results of quality audits and reaudits shall be documented, as required by 21 CFR § 820.22. Specifically,

Passage 7
Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented, as required by 21 CFR § 820.20(c). Specifically,

Passage 8
Failure to adequately address the matters discussed in this letter may result in legal action being initiated by the FDA without further notice. These actions may include, but are not necessarily limited to, seizure, injunction, and civil money penalties.

Citations in the original letter

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

21 CFR 801.20(a)
21 CFR 801.3
21 CFR 801.40(a)(1)
21 CFR 801.40(a)(2)
21 CFR 801
21 CFR 807.81(b)(1)
21 CFR 820.30(i)
21 CFR 820.100(a)
21 CFR 820.198
21 CFR 820.198(e)
21 CFR 820.80(b)
21 CFR 820.184
21 CFR 820.22
21 CFR 820.20(c)
21 CFR 830
21 CFR 830.300(a)
21 CFR 830.3