FDA Inspection
Amneal Pharmaceuticals, LlcAmneal Pharmaceuticals, Llc – FDA Inspection, Oct 25, 2017
Record Details
This FDA Inspection record concerns Amneal Pharmaceuticals, Llc, with an inspection on October 25, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 2f6c33c4-e553-4b5f-a644-195dc77102f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029733
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 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 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 |
| November 10, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Amneal Pharmaceuticals, Llc
- FDA Inspection 989412 - 2016-10-13
- FDA Inspection 854082 - 2013-11-13
- FDA Inspection 767064 - 2012-02-10
- FDA Inspection 663872 - 2010-05-26
- FDA Inspection 545906 - 2008-11-10
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