FDA Inspection
Chartwell Pharmaceuticals LLCChartwell Pharmaceuticals LLC – FDA Inspection, Nov 18, 2025
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals LLC, with an inspection on November 18, 2025, issued by the New York District Office, covering human drugs.
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ID · 11d3e553-14c5-43ff-beb2-f6ce814ef92c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1277530
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
15- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.101(b)Identification of new containers
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(2)In-process sample representation/identification
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Chartwell Pharmaceuticals LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2024 | Not classified | New York District Office | Drug Quality Assurance |
| May 31, 2024 | OAI | New York District Office | Generic Drug Evaluation |
| April 8, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 24, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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