# Chartwell Pharmaceuticals LLC - Inspection Records

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

> Inspection records and compliance data for Chartwell Pharmaceuticals LLC in Congers, New York. Access full analysis and detailed observations.

---

## Details

- Name: Chartwell Pharmaceuticals LLC
- FEI Number: 3008897678
- City: Congers
- State: New York
- Country Name: United States
- Address Line 1: 77 Brenner Dr
- Zip Code: 10920
- Business Operations: API/FDF ANALYTICAL TESTING, FDF MANUFACTURE, PACK, REPACK

## Related Documents

- [FDA Inspection 1277530 - Chartwell Pharmaceuticals LLC - 2025-11-18](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/11d3e553-14c5-43ff-beb2-f6ce814ef92c) — classification: Official Action Indicated (OAI), source: FDA, date: November 18, 2025
- [483 - Chartwell Pharmaceuticals LLC - 2024-12-19](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/e57b74b6-1c7e-468d-a5ea-639527e9f04f) — source: FDA, date: December 19, 2024
- [483 - Chartwell Pharmaceuticals LLC - 2024-12-19](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/3e48e10b-d9ec-463f-a2bc-238f0af3f5d1) — source: FDA, date: December 19, 2024
- [FDA Inspection 1257321 - Chartwell Pharmaceuticals LLC - 2024-12-19](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/3e0c11bf-5154-4697-a1d6-e2ef77dec14b) — source: FDA, date: December 19, 2024
- [FDA Inspection 1257321 - Chartwell Pharmaceuticals LLC - 2024-12-19](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/5e708f24-2e9e-4c56-8797-4d6e0fdc2511) — source: FDA, date: December 19, 2024
- [FDA Inspection 1236033 - Chartwell Pharmaceuticals LLC - 2024-05-31](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/3dfcf0f2-695e-4a28-bd9d-da2684dfb317) — classification: Official Action Indicated (OAI), source: FDA, date: May 31, 2024
- [FDA Inspection 1230475 - Chartwell Pharmaceuticals LLC - 2024-04-08](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/5ec0a18a-b66a-4f89-afe2-a2bdaa564862) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 8, 2024
- [FDA Inspection 1230475 - Chartwell Pharmaceuticals LLC - 2024-04-08](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/8d444b79-8c46-47c6-be01-f5119734136c) — classification: Voluntary Action Indicated (VAI), source: FDA, date: April 8, 2024
- [483 - Chartwell Pharmaceuticals LLC - 2023-05-24](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/de95b640-b564-4faf-9ca2-063958f30e33) — source: FDA, date: May 24, 2023
- [FDA Inspection 1206056 - Chartwell Pharmaceuticals LLC - 2023-05-24](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/477cac0d-4d79-4668-bd49-e0a78e758ada) — classification: Voluntary Action Indicated (VAI), source: FDA, date: May 24, 2023
- [EIR - Chartwell Pharmaceuticals LLC - 2018-09-26](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/febb7431-dc16-4582-9cac-14e565fe0c46) — source: FDA, date: September 26, 2018
- [483 - Chartwell Pharmaceuticals LLC - 2018-09-26](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-llc/232c0466-d828-4e9d-98f0-611b166f288d) — source: FDA, date: September 26, 2018
- [FDA Inspection 1068395 - Chartwell Pharmaceuticals LLC - 2018-09-26](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/ce599aaf-7679-4329-b697-cd159f9d72e3) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 26, 2018
- [EIR - Chartwell Pharmaceuticals LLC - 2016-11-01](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-llc/10f0c1e9-8bf5-4caf-9779-dad27ca98df7) — source: FDA, date: November 1, 2016
- [FDA Inspection 992472 - Chartwell Pharmaceuticals LLC - 2016-11-01](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/f1e70b76-0219-4f41-b798-ec9d93e3d1c8) — classification: Voluntary Action Indicated (VAI), source: FDA, date: November 1, 2016
- [FDA Inspection 885844 - Chartwell Pharmaceuticals LLC - 2014-06-23](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-llc/1490f14f-3203-4181-b468-17b954755658) — classification: No Action Indicated (NAI), source: FDA, date: June 23, 2014

## Related Companies

- [Sovereign Pharmaceuticals, LLC](https://www.keypedia.com/companies/sovereign-pharmaceuticals-llc/b8432227-cad1-4c55-91cc-a8c613f765fd)
- [Appco Pharma LLC](https://www.keypedia.com/companies/appco-pharma-llc/b4a77ba5-0e8a-47ae-94c2-951f5a0b2100)
- [Hospira, Inc.](https://www.keypedia.com/companies/hospira-inc/d4decc1e-4b42-43bb-be2c-abcefbc7b965)
- [The Procter & Gamble Manufacturing Company](https://www.keypedia.com/companies/the-procter-gamble-manufacturing-company/ceebac3f-c234-4225-b666-964153cdba97)
- [Lusomedicamenta Sociedade Tecnica Farmaceutica S.A](https://www.keypedia.com/companies/lusomedicamenta-sociedade-tecnica-farmaceutica-sa/f5b2b06c-020e-4078-9766-b6b28bc61e65)
- [Medical Products Laboratories, Inc.](https://www.keypedia.com/companies/medical-products-laboratories-inc/7e417525-325c-4b38-9007-cee432ed2387)
- [Cronus Pharma Specialities India Pvt Ltd](https://www.keypedia.com/companies/cronus-pharma-specialities-india-pvt-ltd/5eba515d-716e-4acb-b927-57e4973bb0c4)
- [Alk-abello, Inc.](https://www.keypedia.com/companies/alk-abello-inc/88a052a0-f653-45ca-a45e-89003e4e8565)
- [Sharp Clinical Services, LLC](https://www.keypedia.com/companies/sharp-clinical-services-llc/d1817364-b3cb-41a2-818e-dea1083e5827)
- [PTI Georgia, LLC](https://www.keypedia.com/companies/pti-georgia-llc/a1dea629-43b4-4dda-963c-1b320b0311a5)

## Related Officers

- [Director, Team Biologics Staff](https://www.keypedia.com/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)
- [company_representative](https://www.keypedia.com/people/kimberly-a-ezdebski/be201024-152e-4f54-ac07-5a233630c8f3)
- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)
