# FDA 483 - Chartwell Pharmaceuticals LLC - December 19, 2024

Source: https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-llc/3e48e10b-d9ec-463f-a2bc-238f0af3f5d1

> FDA 483 for Chartwell Pharmaceuticals LLC on December 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals LLC
- Inspection Date: 2024-12-19
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Chartwell Pharmaceuticals LLC in Congers, NY, revealed significant deficiencies in manufacturing and quality control. The firm failed to validate numerous manufacturing and packaging processes, lacked proper equipment qualification and cleaning validation, and exhibited issues with cross-contamination control and master batch records. These findings indicate a systemic lack of adherence to good manufacturing practices.

## Related Documents

- [EIR - 2016-11-01](https://www.globalkeysolutions.net/records/eir/chartwell-pharmaceuticals-llc/10f0c1e9-8bf5-4caf-9779-dad27ca98df7)
- [483 - 2018-09-26](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-llc/232c0466-d828-4e9d-98f0-611b166f288d)
- [483 - 2023-05-24](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-llc/de95b640-b564-4faf-9ca2-063958f30e33)

## Related Officers

- [Alisha B. Patel](https://www.globalkeysolutions.net/people/alisha-b-patel/3c106dac-0e0d-41f2-9f7a-69982d4e6579)
- [Josh Renzo N. Ramilo](https://www.globalkeysolutions.net/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)

Company: https://www.globalkeysolutions.net/companies/chartwell-pharmaceuticals-llc/4a8c4844-be98-403a-8cb5-5fc90d592679

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d