Hubei Kangzheng Pharmaceutical Co., Ltd. — FDA Warning Letter Findings
US FDAPublished 2022-01-114 findingsStability and storageAseptic processing and sterility assuranceDeviation, CAPA, and investigationCleaning validation
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). During the inspection, you acknowledged that you do not have a written stability program for your pi yen chin drug product, and were unable to provide data to demonstrate that its chemical, physical, and…
2Aseptic processing and sterility assurance
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). You failed to demonstrate that your manufacturing process is capable of preventing microbial contamination of your over-the-counter (OTC) drug product, pi yen chin ophthalmic redness reliever drops, containing…
3Deviation, 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 failed to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. For example, • You did not initiate an investigation when the infrared (IR) spectrum of naphazoline HCl active pharmaceutical ingredient (API)…
4Cleaning validation
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). Your cleaning validation and verification program for manufacturing equipment is inadequate to prevent cross…
About this record
Extracted automatically from the document US FDA published on 2022-01-11. 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.
