# FDA 483 - Schering-Plough Products LLC - February 16, 2001

Source: https://www.keypedia.com/records/483/schering-plough-products-llc/e7f8f537-3fec-45b3-afac-b8aa185b2d32

> FDA 483 for Schering-Plough Products LLC on February 16, 2001. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Schering-Plough Products LLC
- Inspection Date: 2001-02-16
- Product Type: Drugs
- Office Name: San Juan District Office
- Summary: The FDA Form 483 details numerous deficiencies in laboratory investigations, quality systems, and manufacturing processes.

**Laboratory Investigations:** The facility's failure investigations are inadequate, characterized by re-testing without scientific justification until passing results are obtained, and a lack of corrective actions. Examples include investigations 00 EXTR-211 and 00 EXTR-200 for Theophylline pellets, where failing results were invalidated or not addressed with evidence-backed conclusions or corrective actions. Similar issues were found in investigations 00 Rmat-73, 00 Rmat-81, 00 Rmat-85, and 00 Rmat-89 for Ribavirin drug substance, where re-testing continued until passing results were achieved, leading to lot release. The potency OOS investigation 99-RMAT-23 for API Ribavirin USP was inadequate, with an attributed cause (shaker vs. sonic) not addressed in procedures or applied to other lots. Incorrect re-testing practices were also observed for Ribavirin 200 mg capsules, where OOS results were attributed to analyst inexperience, leading to multiple re-tests and eventual release. Stability OOS investigations 00-STAB-86 and 00-STAB-87 also involved multiple re-tests and invalidation of original data without sufficient justification. The analytical laboratory investigation SOP is inadequate for failing to require FDA

## Related Officers

- [Carlos A. Medina](https://www.keypedia.com/people/carlos-a-medina/1e357ab0-15fd-471f-a4df-28a519fdd2d7)
- [USFDA/Director Division of International Drug Quality/CDER OC](https://www.keypedia.com/people/carmelo-rosa/cfc7c00c-9e11-485e-babe-f7726a7796a7)

Company: https://www.keypedia.com/companies/schering-plough-products-llc/ddcfc992-4600-4112-af66-b5100b365d1e

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8