Makra Kozmetika D.O.O. — FDA Warning Letter Findings

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. (21 CFR 211.22(a) and 211.22(d)). Your firm failed to establish a quality unit (QU). Additionally, you failed to ensure that adequate specifications were established for the drug products, (b)(4) and (b)(4) Ointment, you manufacture and to ensure each batch was tested for, and conformed to, all…

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)). Inadequate Process Controls Your production batch records were inadequate to ensure consistent manufacture of your OTC drug products. Your (b)(4) Ointment batch records lacked critical manufacturing parameters. You…

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. 211.84(d)(1) and 211.84(d)(2)). Your firm failed to test incoming raw materials including active pharmaceutical ingredients (API) (e.g., (b)(4) ) and other components (e.g., (b)(4) ) used to manufacture your OTC drug products to determine…

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, and conduct for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). Your firm failed to conduct quality control testing…