FDA Inspection
Chartwell Pharmaceuticals Carmel LLCChartwell Pharmaceuticals Carmel LLC – FDA Inspection, Jan 11, 2024
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Carmel LLC, with an inspection on January 11, 2024, issued by the New York District Office, covering human drugs.
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ID · 8dfe4c52-bd98-4a8e-8c82-e8677db2cdad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1227007
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Computer control of master formula records
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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 |
| 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 |
| November 2, 2015 | 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 1181090 - 2022-10-06
- FDA Inspection 1112833 - 2019-12-16
- FDA Inspection 1043109 - 2018-02-28
- FDA Inspection 947416 - 2015-11-02
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