Drugs · Dec 12, 2023

Omeza LLC

6 extracted findings

FDA source excerpt, selected passage

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin (21 CFR 211.56(a)).

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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)).

You failed to adequately test your incoming components for identity before using the components in your drug products. Additionally, your firm accepted components from suppliers without establishing the reliability of your suppliers’ test analyses.

Your firm failed to follow a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

You failed to follow your written stability procedures for your lidocaine lavage and skin protectant drug products. You inappropriately used stability data from a different product to establish a **(b)(4)** month expiration date for all your drug products.

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.

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As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 211.56(a)21 CFR 211.84(d)(1)21 CFR 211.166(a)21 CFR 201.128 21 CFR 201.66(b)(2)21 CFR 201.66(b)21 CFR 21021 CFR 330

Omeza LLC

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