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). Your firm failed to investigate out-of-specification (OOS) assay results for several batches of your OTC drug products. For example, (b)(4) product batches (b)(4) and (b)(4) were initially found to be OOS for assay. An investigation into the initial OOS…
2Cleaning validation
Your firm failed to follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). You did not validate the cleaning processes used for cleaning non-dedicated manufacturing equipment, such as your kettle tanks, which are used for different human drug products. You also did not perform testing to ensure that residues of your cleaning agent are adequately removed. In addition, you lacked adequate solution stability data to support the length…
3Stability and storage
Your firm failed to establish 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)). Your firm failed to establish an adequate stability program and determine appropriate expiration dates for the over-the-counter (OTC) drug products that you manufacture. Specifically: You assigned a (b)(4) expiry period…
4Quality unit oversight
Your firm failed to maintain written records so that the quality standards of each drug product can be evaluated at least annually to determine the need for changes in drug product specifications, manufacturing, or control procedures (21 CFR 211.180(e)). You failed to conduct annual product reviews (APR) covering all the human drug products you manufacture, despite having a written and established procedure requiring them. During the inspection, an APR for only one of your…
About this record
Extracted automatically from the document US FDA published on 2023-04-18. 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.
