FDA 483 - Schering-Plough Products, LLC. - June 13, 2001

This FDA Form 483 details significant deficiencies in the firm's quality system, manufacturing processes, and microbiological controls.

**Facility and Operation Details:** The inspection covers the manufacturing of various pharmaceutical products, including Celestone Soluspan Suspension, Celestone, Canymicin Cream, Gentamycin Sulfate, Garamycin Cream, Imitrex Injections, Afrin Nasal Sprays, Optimmune Ophthalmic Ointment, Integrilin Injection, Nasonex Nasal Spray, Nuflor Injection, Bacteriostatic WFI, Azium Solution, Celestone Phosphate Injection, Nubion Injection, Gentocin Solution, Diprolene Topical, and Elocon ointment.

**Violations and Observations:** 1. **Inadequate Production and Control Information Verification:** The firm lacks an adequate system to verify the accuracy of production and control information. * Personnel provided conflicting information regarding stability testing for Celestone Soluspan Suspension, initially stating it was performed, then admitting it was not. * Out-of-guideline (OOG) results for degradation products and impurities in Celestone Soluspan Suspension were observed. * Discrepancies in investigation report dates and batch numbers were noted (e.g., Celestone Soluspan Suspension MRB 20-010071, Lab Investigation #01-F2-03, 01-F2-15). * Lack