# Chartwell Pharmaceuticals LLC – FDA Inspection, Nov 18, 2025

Source: https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/11d3e553-14c5-43ff-beb2-f6ce814ef92c
Source feed: FDA_Inspections

> FDA inspection 1277530 of Chartwell Pharmaceuticals LLC, November 18, 2025. Classification: Official Action Indicated (OAI). 15 citations under 21 CFR part 211. Form 483 issued. 8 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1277530
- Company Name: Chartwell Pharmaceuticals LLC
- Inspection Date: 2025-11-18
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Drug Quality Assurance
- Product Type: Human Drugs
- Center: Human Drugs
- Office Name: New York District Office
- Citation Count: 15

## Related Documents

- [FDA Inspection 1257321 - 2024-12-19](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/5e708f24-2e9e-4c56-8797-4d6e0fdc2511)
- [FDA Inspection 1236033 - 2024-05-31](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/3dfcf0f2-695e-4a28-bd9d-da2684dfb317)
- [FDA Inspection 1230475 - 2024-04-08](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/8d444b79-8c46-47c6-be01-f5119734136c)
- [FDA Inspection 1206056 - 2023-05-24](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/477cac0d-4d79-4668-bd49-e0a78e758ada)
- [FDA Inspection 1068395 - 2018-09-26](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/ce599aaf-7679-4329-b697-cd159f9d72e3)

## Related Officers

- [Lata C. Mathew](https://www.keypedia.com/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)
- [FDA Associated Person](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [FDA Associated Person](https://www.keypedia.com/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

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