FDA Inspection
Chartwell Pharmaceuticals Carmel LLCChartwell Pharmaceuticals Carmel LLC – FDA Inspection, Mar 25, 2013
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Carmel LLC, with an inspection on March 25, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 25, 2013
- Product Type
- Drugs
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ID · 6e5e902b-2648-488a-b7f4-1e11304cfa06
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823212
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.113(a)Procedures for non-sterile drug products
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Other FDA inspections of Chartwell Pharmaceuticals Carmel LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| December 20, 2024 | OAI | New York District Office | Generic Drug Evaluation |
| January 11, 2024 | OAI | New York District Office | Generic Drug Evaluation |
| October 6, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 16, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 28, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chartwell Pharmaceuticals Carmel LLC
- FDA Inspection 1257461 - 2024-12-20
- FDA Inspection 1227007 - 2024-01-11
- FDA Inspection 1181090 - 2022-10-06
- FDA Inspection 1112833 - 2019-12-16
- FDA Inspection 1043109 - 2018-02-28
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