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 failed to adequately validate your alternative (b)(4) microbiological test methods. Your firm…
2Deviation, 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). You failed to adequately investigate multiple microbiological out-of-limit (OOL) and chemical out-of-specification (OOS) results from testing the water you used to manufacture over-the-counter (OTC) (b)(4) drug products, including (b)(4) and (b)(4) . For…
3Quality unit oversight
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, and your firm’s quality control unit did not review and approve those procedures, including any changes (21 CFR 211.100(a)). You failed to ensure adequate validation for each of the manufacturing processes used to produce your OTC drug…
4Quality unit oversight
Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)). The records and information you provided demonstrate that…
5Material 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 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…
