# FDA 483 - Chartwell Pharmaceuticals LLC - May 24, 2023

Source: https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/de95b640-b564-4faf-9ca2-063958f30e33

> FDA 483 for Chartwell Pharmaceuticals LLC on May 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals LLC
- Inspection Date: 2023-05-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Chartwell Pharmaceuticals LLC, a drug manufacturer in Congers, NY, was inspected by the FDA and received six observations. The inspection revealed significant deficiencies in stability data, quality control unit procedures, employee training, production hold times, and facility/equipment readiness for new product manufacturing. These issues indicate a broad lack of adherence to good manufacturing practices.

## Related Documents

- [EIR - 2016-11-01](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/10f0c1e9-8bf5-4caf-9779-dad27ca98df7)
- [483 - 2018-09-26](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/232c0466-d828-4e9d-98f0-611b166f288d)
- [483 - 2024-12-19](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/3e48e10b-d9ec-463f-a2bc-238f0af3f5d1)

## Related Officers

- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Ankur C. Patel](https://www.keypedia.com/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961