Complaint and recall handling Findings

Aw@ -Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established in the application.

Your response fails to address the specific deficiencies in the cited investigations and non-conformances. For the particulate complaint (COMP-2025-0005), your firm did not determine root cause for the confirmed cellulose particles or translucent fibers found in the returned vials or the retain sample, reconcile the particulate finding in the retain sample with the multiple particulates observed in the returned vials, or implement corrective actions for the visual inspection failure that allowed particulates to reach distributed product. You classified cellulose as an “intrinsic” particle without scientific justification, despite potential sources (e.g., cleaning wipes) indicating extrinsic contamination. Your response does not clearly commit to identifying and characterizing all observed particulates (including fibers and residues) in future investigations, nor does it define when such identification is required. Additionally, although you revised POL-030 (Product Complaint Handling) and implemented a training checkpoint, you did not provide evidence that the training was completed and did not establish a defined effectiveness verification plan for these corrective actions. For the batches released despite exceeding critical defect limits, your responses rely on retrospective risk assessments, passing targeted/second 100% reinspection and (b)(4) AQL without thorough root-cause investigations or (b)(4) process corrections for recurring defects (e.g., dislodged caps, partially crimped seals, particulates). These risk assessments are outcome-based, focusing primarily on the absence of complaints or adverse events rather than evaluating the adequacy of your production and inspection controls. Furthermore, lot disposition for batches exceeding the (b)(4) critical reject rate was contingent on the outcome of a pending risk analysis (ISSUE-2025-0008) rather than on a completed investigation and upstream correction, indicating that risk assessment is being used as a substitute for corrective action rather than a complement to it. You also provided no scientific justification for limiting reinspections to preselected defect types rather than conducting a comprehensive 100% visual inspection across all potential defects, and you provided no evidence that CAPA-2025-0017 has been completed. This pattern of relying on reinspection and risk review to achieve passing results, without addressing underlying process failures, fails to demonstrate that the root causes of these defects have been identified, addressed, or controlled.

The written procedures for recalls were inadequate.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

The written procedures for recalls were inadequate.

The written procedures for recalls were inadequate.