Company
United StatesChartwell Pharmaceuticals Carmel LLC, Carmel, NY – FDA Inspections
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.
Company Profile
This profile covers Chartwell Pharmaceuticals Carmel LLC based in Carmel, New York, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 2
- VAI
- 7
- NAI
- 3
- Form 483s
- 3
- Warning letters
- 0
First inspected April 22, 2009. Last inspected December 20, 2024.
Most cited issue areas
- Computer control of master formula records2 inspections
- Equipment Design, Size and Location2 inspections
- Actual vs. theoretical yields not determined1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 20, 2024 | OAI | Human Drugs · Generic Drug Evaluation | 1257461 |
| January 11, 2024 | OAI | Human Drugs · Generic Drug Evaluation | 1227007 |
| October 6, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1181090 |
| December 16, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1112833 |
| February 28, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1043109 |
| November 2, 2015 | VAI | Human Drugs · Drug Quality Assurance | 947416 |
| December 23, 2013 | VAI | Human Drugs · Drug Quality Assurance | 860977 |
| April 25, 2013 | NAI | Human Drugs · Drug Quality Assurance | 829380 |
| March 25, 2013 | VAI | Human Drugs · Drug Quality Assurance | 823212 |
| March 7, 2013 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 820840 |
| July 21, 2010 | VAI | Human Drugs · Drug Quality Assurance | 671709 |
| April 22, 2009 | NAI | Human Drugs · Bioresearch Monitoring | 577354 |
FDA documents
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Company Information
Name
Chartwell Pharmaceuticals Carmel LLC
FEI Number
3009686761
Address
1033 Stoneleigh Ave, Carmel, New York 10512, United States
Country
United States
ID: 7d10681a-1557-4f23-bde4-a9fad718e27f