# FDA 483 - Chartwell Pharmaceuticals Carmel LLC - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/6f18c8a4-903a-4d41-a3c7-07e7650a7b6c

> FDA 483 for Chartwell Pharmaceuticals Carmel LLC on December 20, 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: 2024-12-20
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Chartwell Pharmaceuticals Carmel LLC in Carmel, NY, revealed significant deficiencies in manufacturing practices. Observations included inadequate controls to prevent penicillin cross-contamination, incomplete equipment performance qualifications, and insufficient cleaning procedures for manufacturing equipment. These issues indicate a risk to drug product safety, identity, strength, quality, and purity.

## 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 - 2024-01-11](https://www.globalkeysolutions.net/records/483/chartwell-pharmaceuticals-carmel-llc/10578ab7-79eb-4fa2-b5ee-a9ad021dae5e)

## Related Officers

- [Andrew O. Ejiofor](https://www.globalkeysolutions.net/people/andrew-o-ejiofor/6f256c75-79a4-41a0-a51b-480d5db8f3da)
- [investigator](https://www.globalkeysolutions.net/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)
- [Investigator](https://www.globalkeysolutions.net/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

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

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