Findings
1Material and supplier control
Your firm failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use. (21 CFR 211.84(d)(6)). Your firm produces (b)(4) water that is used as a component in the production of many of your OTC drug products. Your firm failed to adequately monitor the microbiological quality of the water you use to manufacture your aqueous-based OTC drug products. Specifically, you…
2Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). Your firm is a contract manufacturer of over-the-counter (OTC) drug products, including oral cough and cold drug products marketed for both adults and children. You failed to perform adequate identity testing of each component lot used in the manufacture of your OTC drug products, including (b)(4) and dextromethorphan active pharmaceutical…
3Process 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)). Your firm failed to adequately validate your production and process controls. As such, you do not have assurance that you are capable of consistently manufacturing OTC drug products with defined quality attributes…
About this record
Extracted automatically from the document US FDA published on 2023-12-26. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
