Findings
1Other quality system
Failure to ensure that API lots meet specifications prior to blending with other lots. You failed to perform analytical testing prior to the final blend of (b)(4) intermediate lots. Your final blend consisted of up to (b)(4) intermediate lots. This practice may result in the blending of lots not meeting specifications and unreliable results reported for your finished API. In your response, you commit to implement top, middle, and bottom sampling of each container for…
2Process validation
Failure to demonstrate that your manufacturing process can reproducibly manufacture an intermediate and API meeting its predetermined quality attributes. You failed to adequately validate your porcine thyroid API manufacturing processes, including the (b)(4) of (b)(4) intermediates. Additionally, the (b)(4) process validation was not representative of your current manufacturing process. For example: You based your (b)(4) process for (b)(4) intermediates on your (b)(4) room…
3Complaint and recall handling
Failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and API lots to meet specifications. You failed to adequately investigate OOS results. For example: You received a customer complaint for an OOS microbial result for full-strength porcine thyroid API. The complaint lot was composed of (b)(4) sublots of (b)(4) intermediate, two of which were reprocessed due to potential Escherichia coli ( E. coli )…
About this record
Extracted automatically from the document US FDA published on 2023-10-31. 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.
