Findings
1Deviation, 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 contract manufacture homeopathic and over-the-counter (OTC) drug products including those intended for infants and children and labeled “safe for newborn.” Lubricant Contamination You failed to perform adequate investigations and expand…
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)). You lacked testing for each shipment of each lot of components at high risk of diethylene glycol (DEG) and ethylene glycol (EG) contamination, used in the manufacture of your drug products. For example, you lacked a specific identity test to detect DEG and EG in all lots of glycerin and propylene glycol, prior to determining acceptability for use in…
3Laboratory and QC controls
Your firm failed to establish the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)). You failed to adequately validate your alternative rapid microbiological test methods, demonstrate they were equivalent to, or better than USP compendial methods, and suitable for their intended use. For example, our investigators observed the (b)(4) system used for rapid microbiological release testing (total counts, objectionable…
About this record
Extracted automatically from the document US FDA published on 2023-08-15. 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.
