FDA 483 - Schering-Plough Products, LLC. - December 14, 2000

This FDA Form 483 details multiple observations from an inspection.

**Facility and Operations:** The firm manufactures Gentamicin otic solution, Mometasone Furoate Active Pharmaceutical Ingredient (API), Nasonex Nasal Spray, and Garamycin ophthalmic solution.

**Violations and Observations:**

* **Gentamicin Otic Solution Contamination:** Since February 1999, stability testing revealed an unknown peak in the Betamethasone Valerate assay, identified in October 2000 as Dioctylocetyl Phthalate (DCHP) at 5,800 ug/bottle, leaching from the label adhesive. The firm continued distribution without ensuring safety/efficacy or investigating effects on other products using the same adhesive (e.g., Garamycin ophthalmic solution). * **Mometasone Furoate API Manufacturing Process Validation:** The process is not validated. Issues include: no specific validation protocol, predetermined specifications dated after batch manufacturing, uninvestigated discrepancies between in-process and QC lab appearance results (failing vs. meeting spec), lack of scientific/statistical justification for sampling plan, and un-described analytical sample location/size. * **Sampling Procedures:** Operators used a small plastic spatula instead of the required sampling thief for in-process samples, which was unavailable. * **Mometasone Furoate Reprocessing:** 30% of 2000 lots required reprocessing. An investigation