Schering-Plough Products, L.L.C. – FDA 483, Jul 24, 2015

The FDA Form 483 details multiple deficiencies at a pharmaceutical manufacturing facility.

**Laboratory Control Deficiencies:** * **Method Validation:** Lack of documented validation for analytical methods, specifically the Perphenazine Assay Stability method for Trilafon injection. * **Procedure Adherence:** The Benzalkonium Chloride stability assay procedure (938.56.03) for Garamycin Ophthalmic solution does not reflect current practice regarding composite sample testing, and there's no documentation of composite sample preparation/testing. * **OOS/OOG Procedures:** Procedures GMP 145.143.00 (Retest/Resample for OOS/OOG) and GMP 145.142.01 (Analytical Laboratories Investigations) lack defined steps for re-injection non-confirmation, leading to case-by-case decisions. * **Data Backup:** No backup file for laboratory UV Spectrophotometers, resulting in lost data (e.g., Banamine Solution samples 9-CNX-123, 8-9-CNX-218) and requiring re-preparation. * **Spray Content Calculation:** Inadequate laboratory practice for calculating Uniformity of Spray Content for Vancenase AQ Nasal Suspension and Nasonex, where only individual OOS results were retested and averaged with original values.

**Regulatory Reporting Failures:** * **