FDA Inspection
Energy Los Alamos Office, United States Department ofEnergy Los Alamos Office, United States Department of – FDA Inspection, Jan 5, 2018
Record Details
This FDA Inspection record concerns Energy Los Alamos Office, United States Department of, with an inspection on January 5, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 5, 2018
- Product Type
- Drugs
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ID · 09ec3959-c996-4034-b6f4-bbf66630bd69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1037004
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.40(d)Contamination, mix-ups and deterioration
- 21 CFR 212.50Adequate controls (general)
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Other FDA inspections of Energy Los Alamos Office, United States Department of
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Energy Los Alamos Office, United States Department of
- FDA Inspection 842650 - 2013-07-31
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