AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp

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 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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)).

Passage 3

Your firm failed to complete equipment and process performance qualification (PPQ) prior to releasing your OTC drug products. Likewise, you lacked appropriate documentation, qualification, maintenance, and monitoring of your purified water system, which is used in the manufacture of your OTC drug products.

Passage 4

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 5

You failed to adequately test your incoming components, including propylene glycol and active ingredients such as minoxidil, for identity before using them in the manufacture of your OTC drug products. Additionally, you relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of each of your suppliers’ analyses at appropriate intervals.

Passage 6

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.