Pharmedica USA, 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 establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Passage 2

You failed to adequately qualify the equipment and validate the processes used to manufacture your drug products. You have not performed process performance qualification (PPQ) studies, nor do you have an ongoing program for monitoring process control, to ensure stable manufacturing operations and consistent drug quality for products in U.S. distribution.

Passage 3

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, and conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. (21 CFR 211.165(a) and 21 CFR 211.165(b)).

Passage 4

Your firm failed to conduct adequate release testing of all your drug products. For example:

Passage 5

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Passage 6

Your firm failed to conduct adequate testing on the components used to manufacture your finished drug products (e.g., ophthalmic product, nasal spray). Additionally, your firm accepts components from your suppliers without establishing the reliability of your suppliers’ test analyses, and you did not obtain or review the suppliers’ certificate of analysis (COA) for all components (e.g., methylsulfonylmethane (MSM), **(b)(4)** water).

Passage 7

Your firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacture of your drug products. For example, you failed to ensure:

Passage 8

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.