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

Source: https://www.keypedia.com/records/483/schering-plough-products-llc/def991fd-0b51-4e45-9b2e-221e0b29d772

> FDA 483 for Schering-Plough Products, LLC. on December 14, 2000. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Schering-Plough Products, LLC.
- Inspection Date: 2000-12-14
- Product Type: Drugs
- Office Name: San Juan District Office
- Summary: 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

## Related Documents

- [483 - 2001-06-13](https://www.keypedia.com/records/483/schering-plough-products-llc/9a75c880-ad3d-42fc-869e-4e9f30a1d2e9)
- [483 - 2001-02-16](https://www.keypedia.com/records/483/schering-plough-products-llc/c616de99-6f2c-4612-9551-47550f95e608)

## Related Officers

- [Coordinator](https://www.keypedia.com/people/wanda-j-torres/8c2c8963-2a8a-4dda-b5cf-c87e52705f45)
- [District Director at FDA](https://www.keypedia.com/people/steven-barber/e766c0f7-0002-400f-b83a-a0a6efbf259c)

Company: https://www.keypedia.com/companies/schering-plough-products-llc/b8bd518e-65c2-428a-85f3-8ff8b7a889a4

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