FDA Inspection
Chartwell Pharmaceuticals Carmel LLCChartwell Pharmaceuticals Carmel LLC – FDA Inspection, Oct 6, 2022
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Carmel LLC, with an inspection on October 6, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 6, 2022
- Product Type
- Drugs
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ID · b9152ad1-4499-4fee-8420-39179726fea2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1181090
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.42(c)(5)Mfg / Processing Operations Area
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.100(a)Approval and review of procedures
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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 |
| 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 1227007 - 2024-01-11
- FDA Inspection 1112833 - 2019-12-16
- FDA Inspection 1043109 - 2018-02-28
- FDA Inspection 947416 - 2015-11-02
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