FDA Inspection
Chartwell Pharmaceuticals Amityville, LLCChartwell Pharmaceuticals Amityville, LLC – FDA Inspection, Nov 12, 2010
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Amityville, LLC, with an inspection on November 12, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 12, 2010
- Product Type
- Drugs
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ID · 3c2dd8ae-5ae6-48ab-b007-67d267b81d3b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 705361
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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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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