InfuTronix LLC

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 analyze processes, work operations, concessions, quality audits reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of non-conforming product, or other quality data problems; and failure to employ appropriate statistical methodology where necessary to detect recurring quality problems, as required by 21 CFR Part 820.100(a)(1).

Passage 2

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(a).

Passage 3

Failure to adequately review, evaluate, and investigate any complaint involving the possible failure of a device to meet any of its specifications, unless such investigation has already been performed and another investigation is not necessary, as required by 21 CFR § 820.198(c).

Passage 4

Failure to submit any report required within 10‐working days of initiating such correction or removal, as required by 21 CFR § 806.10.

Passage 5

Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.

Passage 6

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).