FDA Inspection
Aerocare Holdings IncAerocare Holdings Inc – FDA Inspection, Jun 18, 2010
Record Details
This FDA Inspection record concerns Aerocare Holdings Inc, with an inspection on June 18, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aerocare Holdings Inc
- Inspection Date
- June 18, 2010
- Product Type
- Drugs
View Company Profile
ID · 3733ea4d-dbef-4be8-b768-0d7398dc82c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669080
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.192Quality control unit review of records
- 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 |
| February 7, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Aerocare Holdings Inc
- FDA Inspection 753141 - 2011-10-28
- FDA Inspection 708460 - 2011-02-07
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