Cosmetic Manufacturers Pty Ltd. — FDA Warning Letter Findings

Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63). You have not demonstrated all equipment used to manufacture finished drug products is suitable for its intended use. You qualified the (b)(4) filler machine for the filling of (b)(4) in (b)(4) mL bottles…

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)). You did not ensure drug products manufactured at your facility were evaluated for all critical quality attributes. You did not test (b)(4) drug products for identity and strength of the active ingredient…

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your manufacturing process validation was inadequate for (b)(4) bulk solutions. Your sampling methodologies lacked scientific justification, and you did not you test for the concentration of active ingredient (b)(4)…

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)). (b)(4) is used in the formulation of your (b)(4) products and cleaning of production equipment…