FDA 483 - SCA Pharmaceuticals, LLC - October 20, 2023

The FDA Form 483 inspection revealed significant deficiencies at the facility, primarily concerning quality control, manufacturing processes, and documentation.

**Quality Control Unit Deficiencies:** * No dedicated quality control unit. * Investigation process for particulates is deficient; no requirement to identify particulates or open investigations after 100% visual inspection failures, even when AQL fails or after a second 100% inspection failure. * Visual inspection SOP (ILP-001-W) does not trigger retraining after AQL failures post-100% inspection. * Production employees, not Quality, perform AQL and tightened AQL.

**Manufacturing and Production Issues:** * Visual inspection yield is not calculated or established in batch records (e.g., Hydromorphone HCL 1mg/mL, Fentanyl 50mcg/mL, Hydromorphone HCL 0.2 mg/mL batches showed significant yield variations). * Failure to thoroughly review unexplained discrepancies and batch failures. * SOP TM 008 allows product release without investigation after Test Method 1 (Light Obscuration) failure if Test Method 2 (Microscopic) passes. * Inadequate investigation and remediation of 29 in-house sterility OOS results, particularly for spore-forming microbes (e.g., Phenylephrine HCl lot 12230