# FDA 483 - Chartwell Pharmaceuticals Carmel LLC - October 06, 2022

Source: https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/c9a4caa1-41b6-48fc-8f06-b204dd34c84e

> FDA 483 for Chartwell Pharmaceuticals Carmel LLC on October 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals Carmel LLC
- Inspection Date: 2022-10-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Chartwell Pharmaceuticals Carmel LLC in Carmel, NY, from September 28 to October 6, 2022, revealed significant deficiencies in their quality system. Findings included inadequate review of GMP procedures, lack of proper equipment cleaning validation, insufficient computer system controls, and inaccurate yield calculations. Additionally, the firm failed to maintain appropriate drug product storage conditions and prevent contamination in manufacturing areas.

## Related Documents

- [483 - 2018-02-28](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/e2b1e4ee-6b51-46f3-99ec-d77208ad7557)
- [EIR - 2019-12-16](https://www.globalkeysolutions.net/records/eir/chartwell-pharmaceuticals-carmel-llc/6db710ba-7d7e-4a95-9db8-28b65aa201e2)
- [483 - 2019-12-16](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/8e17e4fb-45af-42a6-8551-1eb58ba205bc)
- [483 - 2024-01-11](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/10578ab7-79eb-4fa2-b5ee-a9ad021dae5e)
- [483 - 2024-12-20](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/6f18c8a4-903a-4d41-a3c7-07e7650a7b6c)

## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)

Company: https://www.globalkeysolutions.net/companies/chartwell-pharmaceuticals-carmel-llc/7d10681a-1557-4f23-bde4-a9fad718e27f

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