FDA Inspection
Avara Aiken Pharmaceutical Services Inc.Avara Aiken Pharmaceutical Services Inc. – FDA Inspection, Jul 10, 2015
Record Details
This FDA Inspection record concerns Avara Aiken Pharmaceutical Services Inc., with an inspection on July 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 10, 2015
- Product Type
- Drugs
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ID · 7286a456-ff56-48b7-b73b-6701d48dbd8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 933389
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.34Consultant Records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(b)Written sanitation procedures not followed
- 21 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
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Other FDA inspections of Avara Aiken Pharmaceutical Services Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 27, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 7, 2008 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Avara Aiken Pharmaceutical Services Inc.
- FDA Inspection 765141 - 2012-01-27
- FDA Inspection 717226 - 2011-01-27
- FDA Inspection 659478 - 2010-04-19
- FDA Inspection 547658 - 2008-11-07
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