# FDA 483 - Chartwell Pharmaceuticals Carmel LLC - January 11, 2024

Source: https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/10578ab7-79eb-4fa2-b5ee-a9ad021dae5e

> FDA 483 for Chartwell Pharmaceuticals Carmel LLC on January 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals Carmel LLC
- Inspection Date: 2024-01-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Chartwell Pharmaceuticals Carmel LLC, a drug manufacturer in Carmel, NY, received a Form 483 with three observations following an FDA inspection. The inspection revealed significant issues including the use of unqualified and uninstalled equipment, inadequate computer system controls leading to data integrity concerns, and a failure to record and justify deviations from approved production and process control procedures. These findings indicate a lack of adherence to cGMP requirements for drug manufacturing.

## 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 - 2022-10-06](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/c9a4caa1-41b6-48fc-8f06-b204dd34c84e)
- [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/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248