Amish Origins Management, 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, 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 conduct adequate release testing of all your drug products prior to distribution. Specifically, you did not test your drug products for identity, assay, impurities, or microbiological attributes.

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

You failed to perform adequate identity testing of each component lot used in the manufacture of your OTC drug products, including for your active ingredient menthol and glycerin. Additionally, you relied on your suppliers’ certificates of analyses (COAs) without establishing the reliability of each of your suppliers’ test analyses at appropriate intervals.

Passage 5

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

Passage 6

You failed to document the manufacturing instructions for your OTC drug products and did not have any executed batch records for distributed drug products.

Passage 7

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.