# FDA 483 - Schering-Plough Products, L.L.C. - July 24, 2015

Source: https://www.keypedia.com/records/483/schering-plough-products-llc/1686d87d-37ae-4306-83f9-20e2a2eadd7f

> FDA 483 for Schering-Plough Products, L.L.C. on July 24, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Schering-Plough Products, L.L.C.
- Inspection Date: 2015-07-24
- Product Type: Drugs
- Office Name: San Juan District Office
- Summary: 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:**
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