FDA Inspection
ROTECHROTECH – FDA Inspection, Sep 13, 2012
Record Details
This FDA Inspection record concerns ROTECH, with an inspection on September 13, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- ROTECH
- Inspection Date
- September 13, 2012
- Product Type
- Drugs
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ID · addfa9ba-567b-4279-a155-192b9a85b680
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 804052
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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