FDA Inspection
Amneal Pharmaceuticals, LlcAmneal Pharmaceuticals, Llc – FDA Inspection, Nov 10, 2008
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, Llc, with an inspection on November 10, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amneal Pharmaceuticals, Llc
- Inspection Date
- November 10, 2008
- Product Type
- Drugs
View Company Profile
ID · 970591bd-3a60-4909-8bf8-121a2c6a7e9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 545906
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
- 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 Amneal Pharmaceuticals, Llc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 13, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 26, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals, Llc
- FDA Inspection 1029733 - 2017-10-25
- FDA Inspection 989412 - 2016-10-13
- FDA Inspection 854082 - 2013-11-13
- FDA Inspection 767064 - 2012-02-10
- FDA Inspection 663872 - 2010-05-26
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