Betone S.A. de C.V. — FDA Warning Letter Findings

Your firm failed to formulate batches of your drug product with the intent to provide not less than 100% of the labeled or established amount of active ingredient (21 CFR 211.101(a)). Your firm failed to ensure that your (b)(4) wipe drug products were formulated to contain the (b)(4) active ingredient at the labeled strength of (b)(4) %. Drug products must be formulated to contain the amount of active ingredient they are represented to possess. In your response, you…

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)). You failed to adequately test your incoming components (e.g., active ingredient (b)(4) , and glycerin) before using the components to manufacture…

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). You failed to establish and maintain an ongoing stability testing program to support the labeled expiry on your distributed drug products. There is no assurance that your drug products will remain acceptable throughout their labeled expiry period without an ongoing stability program. In your response, you state that drug product…

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)). Your firm manufactures over-the-counter (OTC) (b)(4) wipe drug products. Your firm failed to adequately test your (b)(4) wipe drug products for the identity and strength of the active ingredient (b)(4) prior…