# Chartwell Pharmaceuticals Carmel LLC, Carmel, NY – FDA Inspections Source: https://www.keypedia.com/companies/chartwell-pharmaceuticals-carmel-llc/7d10681a-1557-4f23-bde4-a9fad718e27f > Inspection records and compliance data for Chartwell Pharmaceuticals Carmel LLC in Carmel, New York. 12 FDA inspections on record (2 OAI), 3 Form 483s, last inspected December 20, 2024. --- ## Details - Name: Chartwell Pharmaceuticals Carmel LLC - FEI Number: 3009686761 - Business Operations: API/FDF ANALYTICAL TESTING, FDF MANUFACTURE, IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING, PACK, REPACK - Address Line 1: 1033 Stoneleigh Ave - City: Carmel - State: New York - Zip Code: 10512 - Country Name: United States - Address: 1033 Stoneleigh Ave, Carmel, New York 10512, United States - Country: United States ## Related Documents - [483 - Chartwell Pharmaceuticals Carmel LLC - 2024-12-20](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-carmel-llc/6f18c8a4-903a-4d41-a3c7-07e7650a7b6c) — source: FDA, date: December 20, 2024 - [FDA Inspection 1257461 - Chartwell Pharmaceuticals Carmel LLC - 2024-12-20](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-carmel-llc/ccea6d9e-15b4-4ccd-98f6-aa48def54a9a) — classification: Official Action Indicated (OAI), source: FDA, date: December 20, 2024 - [483 - Chartwell Pharmaceuticals Carmel LLC - 2024-01-11](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-carmel-llc/10578ab7-79eb-4fa2-b5ee-a9ad021dae5e) — source: FDA, date: January 11, 2024 - [FDA Inspection 1227007 - Chartwell Pharmaceuticals Carmel LLC - 2024-01-11](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-carmel-llc/8dfe4c52-bd98-4a8e-8c82-e8677db2cdad) — classification: Official Action Indicated (OAI), source: FDA, date: January 11, 2024 - [483 - Chartwell Pharmaceuticals Carmel LLC - 2022-10-06](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-carmel-llc/c9a4caa1-41b6-48fc-8f06-b204dd34c84e) — source: FDA, date: October 6, 2022 - [FDA Inspection 1181090 - Chartwell Pharmaceuticals Carmel LLC - 2022-10-06](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-carmel-llc/b9152ad1-4499-4fee-8420-39179726fea2) — classification: Voluntary Action Indicated (VAI), source: FDA, date: October 6, 2022 - [483 - Chartwell Pharmaceuticals Carmel LLC - 2019-12-16](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-carmel-llc/8e17e4fb-45af-42a6-8551-1eb58ba205bc) — source: FDA, date: December 16, 2019 - [EIR - Chartwell Pharmaceuticals Carmel LLC - 2019-12-16](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-carmel-llc/6db710ba-7d7e-4a95-9db8-28b65aa201e2) — source: FDA, date: December 16, 2019 - FDA Inspection 1112833 - Chartwell Pharmaceuticals Carmel LLC - 2019-12-16 — classification: Voluntary Action Indicated (VAI), source: FDA, date: December 16, 2019 - [EIR - Chartwell Pharmaceuticals Carmel LLC - 2018-02-28](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-carmel-llc/64456685-5a16-4805-9141-0f8cdbc8c631) — source: FDA, date: February 28, 2018 - [483 - Chartwell Pharmaceuticals Carmel LLC - 2018-02-28](https://www.keypedia.com/records/483/chartwell-pharmaceuticals-carmel-llc/e2b1e4ee-6b51-46f3-99ec-d77208ad7557) — source: FDA, date: February 28, 2018 - [FDA Inspection 1043109 - Chartwell Pharmaceuticals Carmel LLC - 2018-02-28](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-carmel-llc/c7dbe340-e231-47d1-9334-57ca14ee53a6) — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 28, 2018 - [EIR - Chartwell Pharmaceuticals Carmel LLC - 2015-11-02](https://www.keypedia.com/records/eir/chartwell-pharmaceuticals-carmel-llc/3743fc5f-65f0-404f-8833-80f2081e18ea) — source: FDA, date: November 2, 2015 - FDA Inspection 947416 - Chartwell Pharmaceuticals Carmel LLC - 2015-11-02 — classification: Voluntary Action Indicated (VAI), source: FDA, date: November 2, 2015 - FDA Inspection 860977 - Chartwell Pharmaceuticals Carmel LLC - 2013-12-23 — classification: No Action Indicated (NAI), source: FDA, date: December 23, 2013 - FDA Inspection 860977 - Chartwell Pharmaceuticals Carmel LLC - 2013-12-23 — classification: Voluntary Action Indicated (VAI), source: FDA, date: December 23, 2013 - [FDA Inspection 829380 - Chartwell Pharmaceuticals Carmel LLC - 2013-04-25](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-carmel-llc/be506673-1f97-4629-8a35-e219e77841c3) — classification: No Action Indicated (NAI), source: FDA, date: April 25, 2013 - [FDA Inspection 823212 - Chartwell Pharmaceuticals Carmel LLC - 2013-03-25](https://www.keypedia.com/records/fda_inspections/chartwell-pharmaceuticals-carmel-llc/6e5e902b-2648-488a-b7f4-1e11304cfa06) — classification: Voluntary Action Indicated (VAI), source: FDA, date: March 25, 2013 ## Related Companies - [The Procter & Gamble Manufacturing Company](https://www.keypedia.com/companies/the-procter-gamble-manufacturing-company/ceebac3f-c234-4225-b666-964153cdba97) - [Sovereign Pharmaceuticals, LLC](https://www.keypedia.com/companies/sovereign-pharmaceuticals-llc/b8432227-cad1-4c55-91cc-a8c613f765fd) - [Lannett Company LLC](https://www.keypedia.com/companies/lannett-company-llc/d4d7f04f-0ec5-4f5a-868b-d48963202cc8) - [BioRamo, LLC](https://www.keypedia.com/companies/bioramo-llc/c32084c1-7762-45e7-aff6-b09ea6dfdf17) - [Almac Pharma Services LLC](https://www.keypedia.com/companies/almac-pharma-services-llc/a5015855-2f01-4474-895d-a397cc89e5fa) - [Appco Pharma LLC](https://www.keypedia.com/companies/appco-pharma-llc/b4a77ba5-0e8a-47ae-94c2-951f5a0b2100) - [PTI Georgia, LLC](https://www.keypedia.com/companies/pti-georgia-llc/a1dea629-43b4-4dda-963c-1b320b0311a5) - [Frontage Laboratories, Inc.](https://www.keypedia.com/companies/frontage-laboratories-inc/1705f97d-14a3-4e46-b8a5-220bf2c4799f) - [Quality Packaging Specialists International, LLC](https://www.keypedia.com/companies/quality-packaging-specialists-international-llc/74a9861b-efac-463e-b6f9-bd1e22db674a) - [Hikma Injectables USA Inc](https://www.keypedia.com/companies/hikma-injectables-usa-inc/9d594ef4-e334-4c2d-a6ed-90845b8c29df) ## Related Officers - [company_representative](https://www.keypedia.com/people/rohit-desai/06592eb6-253e-41bd-9295-e76dbd1223f7) - [company_representative](https://www.keypedia.com/people/mahendra-dedhiya/3b35da3f-5594-48a6-b115-211770ec0521) - [Director, Team Biologics Staff](https://www.keypedia.com/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)