Findings
1Data integrity
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. Your quality unit (QU) failed to ensure adequate document control over paper and electronic records. For example, our investigators observed numerous logbooks, forms, and partially completed “Sample Request For Analysis (Other Than SAP)” in an uncontrolled temporary storage room near your microbiology laboratory. Our investigators also…
2Cleaning validation
Failure to establish and follow written procedures for investigating critical deviations or the failure of API batches to meet specifications. You failed to adequately investigate and determine the root cause of black particles in two batches of (b)(4) API. For example, your investigation report for (b)(4) batch (b)(4) stated the black particles were non-metallic charred product residue. Your report further indicated that the sample was observed by analysis to “dissolve in…
3Environmental monitoring
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity. You failed to ensure that your test procedures were appropriately validated and established procedures were followed. For example, your recovery studies were not adequate to demonstrate that the method for beta-lactam environmental monitoring can recover beta-lactam residue by swab sampling. Additionally, your…
About this record
Extracted automatically from the document US FDA published on 2022-12-13. 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.
