1Laboratory and QC controls
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)). You lacked appropriate sampling and testing to ensure your drug products conform to appropriate…
2Material and supplier control
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 conduct adequate identity testing on incoming components, including APIs, used in the manufacture of your drug products. For example, you failed to adequately test each shipment of each…
3Quality unit oversight
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm failed to establish an adequate QU with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure: Establishment of procedures describing roles and responsibilities of the…
4Process validation
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)). You lacked process validation data to demonstrate you have adequately validated your manufacturing processes used to manufacture your OTC drug products and to demonstrate your processes are reproducible and…
5Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm is a manufacturer of over-the-counter (OTC) drugs for oral, nasal, rectal, and topical use. Your firm’s investigations into unexplained discrepancies are inadequate. Your quality unit (QU) failed to thoroughly investigate all finished product…
