PMS4PMS, LLC

Selected passages from the FDA letter

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

Passage 1

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Passage 2

Your firm failed to adequately determine the appropriate laboratory testing necessary for your OTC drug product. For example, you did not perform testing for identity and strength of the active ingredient prior to release and distribution.

Passage 3

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).

Passage 4

You failed to establish and maintain an adequate stability testing program to support the labeled expiry on your distributed drug products. There is no assurance that your drug products will remain acceptable throughout the assigned 5-year expiry period without an ongoing stability program.

Passage 5

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.