FDA Inspection
United States Department of Health & Human ServicesUnited States Department of Health & Human Services – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns United States Department of Health & Human Services, with an inspection on June 18, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- June 18, 2013
- Product Type
- Drugs
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ID · 08ba15ad-ce5d-4358-8008-0d50d070415c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836346
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of United States Department of Health & Human Services
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 18, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for United States Department of Health & Human Services
- FDA Inspection 1230131 - 2024-01-18
- FDA Inspection 965269 - 2016-04-08
- FDA Inspection 675961 - 2010-08-16
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