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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 establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

Passage 2

Failure to validate with a high degree of assurance a process where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).

Passage 3

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

Passage 4

Failure to adequately maintain complaint files, as required by 21 CFR 820.198(a), failure to review and evaluate all complaints to determine whether an investigation is necessary, as required by 21 CFR 820.198(b), and failure to maintain in a separate portion of the complaint files any complaint that represents an event which must be reported to FDA under part 803, as required by 21 CFR 820.198(d).

Passage 5

Failure to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements, as required by 21 CFR 820.200(a).