# Chartwell Pharmaceuticals LLC – FDA 483, May 31, 2024

Source: https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/ea844b40-9502-4e06-82fc-1db726e9b1be

> FDA 483 for Chartwell Pharmaceuticals LLC on May 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chartwell Pharmaceuticals LLC
- Inspection Date: 2024-05-31
- Product Type: drugs
- Office Name: New York District Office
- Summary: Chartwell Pharmaceuticals LLC in Congers, NY, was cited with five observations during an FDA inspection, primarily concerning significant deficiencies within its quality control unit. The firm failed to adhere to established procedures for change control, record review, and log maintenance, indicating a systemic breakdown in quality oversight. Additional issues included inadequate equipment design and qualification, a failure to record deviations from production and process control procedures, and insufficient laboratory controls for sampling drug products.

## Related Documents

- [483 - 2024-12-19](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/3e48e10b-d9ec-463f-a2bc-238f0af3f5d1) — date: December 19, 2024
- [483 - 2023-05-24](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/de95b640-b564-4faf-9ca2-063958f30e33) — date: May 24, 2023
- [EIR - 2018-09-26](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/febb7431-dc16-4582-9cac-14e565fe0c46) — date: September 26, 2018
- [483 - 2018-09-26](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/232c0466-d828-4e9d-98f0-611b166f288d) — date: September 26, 2018
- [EIR - 2016-11-01](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/10f0c1e9-8bf5-4caf-9779-dad27ca98df7) — date: November 1, 2016

## Related Officers

- [John D. McIntosh](https://www.keypedia.com/people/john-d-mcintosh/063cac5b-0933-4ecf-a9fb-835dd5d25ef2)
- [Stephenie M. Ortiz](https://www.keypedia.com/people/stephenie-m-ortiz/b0923b14-b153-4893-8eb2-f5e6b1fd2041)
- [JoshRenzo N. Ramilo](https://www.keypedia.com/people/joshrenzo-n-ramilo/c88227a7-0b4b-4526-9c56-97c38ab7bcea)
- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)

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

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