FDA Inspection
Aerocare Holdings IncAerocare Holdings Inc – FDA Inspection, Feb 7, 2011
Record Details
This FDA Inspection record concerns Aerocare Holdings Inc, with an inspection on February 7, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aerocare Holdings Inc
- Inspection Date
- February 7, 2011
- Product Type
- Drugs
View Company Profile
ID · 94783817-3ba3-4585-9b20-b80dc308f25b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708460
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Aerocare Holdings Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aerocare Holdings Inc
- FDA Inspection 753141 - 2011-10-28
- FDA Inspection 669080 - 2010-06-18
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