FDA Inspection
Chartwell Pharmaceuticals Amityville, LLCChartwell Pharmaceuticals Amityville, LLC – FDA Inspection, Dec 3, 2009
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Amityville, LLC, with an inspection on December 3, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 3, 2009
- Product Type
- Drugs
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ID · dc128a88-c7a3-4562-a56c-a845d3d286a4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 629631
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Chartwell Pharmaceuticals Amityville, LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| February 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 20, 2017 | Not classified | New York District Office | |
| May 5, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Chartwell Pharmaceuticals Amityville, LLC
- FDA Inspection 1193806 - 2022-12-21
- FDA Inspection 1079804 - 2019-02-13
- FDA Inspection 1020105 - 2017-07-20
- FDA Inspection 1011507 - 2017-05-05
- FDA Inspection 980564 - 2016-07-15
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