Froggy’s Fog LLC — FDA Warning Letter Findings

Your firm failed to perform, 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 21 CFR 211.165(b)). Your firm failed to adequately test your OTC drugs…

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Your firm did not validate your cleaning processes used for cleaning non-dedicated manufacturing equipment. Inadequate removal of residues from the product contact surfaces of manufacturing equipment during cleaning can contaminate drug products subsequently manufactured on non-dedicated equipment. In your response, you stated that you initiated…

Your firm failed to conduct (b)(4) 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 (2)). You have not demonstrated that you adequately test all incoming raw materials used in the manufacture of your drug products, including identity testing on each lot of incoming raw material. For example, your…

Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). Your analytical test methods were not adequately validated, including those for the active…