FDA Inspection
Chartwell Pharmaceuticals Amityville, LLCChartwell Pharmaceuticals Amityville, LLC – FDA Inspection, Oct 19, 2011
Record Details
This FDA Inspection record concerns Chartwell Pharmaceuticals Amityville, LLC, with an inspection on October 19, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 19, 2011
- Product Type
- Drugs
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ID · 38d41ed9-1d5d-4882-a046-ef8f86db8ee0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 750019
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.204Returned drug procedures in writing and followed
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not 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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