Findings citing 21 CFR 211.84

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm manufactures over-the-counter (OTC) (b)(4) drug products such as (b)(4) and ethanol- (b)(4) . You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., glycerin, propylene glycol, ethanol) used in the manufacture of your OTC (b)(4) drug products. Moreover, you used nonpharmaceutical-grade…

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 perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4) ) used in the manufacture of your OTC topical drug products. In addition, you relied on…

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)). Your firm manufactures OTC drug products such as (b)(4) . Based on the records and information you provided, you did not demonstrate that you adequately tested each shipment of each lot of incoming…

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)). Your firm failed to test incoming active pharmaceutical ingredients (APIs) (e.g. (b)(4) ) and other components used to manufacture your OTC drug…

Your firm failed to test samples of each component for conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(2)). Your firm failed to ensure that components used in the manufacture of your over-the-counter (OTC) (b)(4) drug product “ (b)(4) ” are suitable for their intended use. You failed to perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4) ). Products Contain Ingredients…

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)). Your response to our request for records under section 704(a)(4) indicated that you do not test the identity of each incoming component used in the manufacture of your drug products, such as (b)(4)…