Integrity Partners Group

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

Passage 2

Your firm failed to adequately test your over-the-counter (OTC) **(b)(4)** drug products for strength (assay) of each active ingredient prior to release and distribution. You also failed to ensure adequate microbiological testing for each batch of your **(b)(4)** and **(b)(4)** drug products prior to release.

Passage 3

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 4

Your firm failed to perform adequate testing for your raw materials that were used to manufacture the following:

Passage 5

Your firm failed to adequately test for **(b)(4)** in your incoming component **(b)(4)** used as an active pharmaceutical ingredient (API) and as a component in an in-process material. The use of **(b)(4)** contaminated with **(b)(4)** has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document **(b)(4)

Passage 6

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Passage 7

Your firm failed to adequately validate your equipment cleaning process to demonstrate its effectiveness to prevent potential cross-contamination between your OTC drug products and non-pharmaceutical products. You manufactured your OTC **(b)(4)** drug products on non-dedicated equipment, e.g., your **(b)(4)** tank. This equipment was also used to manufacture **(b)(4)** including, but not limited to, **(b)(4)** that is intended for **(b)(4)**.

Passage 8

Your firm failed to establish 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 9

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.