FDA Inspection
Rotech Healthcare, Inc. d.b.a. Rhema MedicalRotech Healthcare, Inc. d.b.a. Rhema Medical – FDA Inspection, Feb 3, 2010
Record Details
This FDA Inspection record concerns Rotech Healthcare, Inc. d.b.a. Rhema Medical, with an inspection on February 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- February 3, 2010
- Product Type
- Drugs
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ID · b8bec4dc-b85b-4f4e-8a9b-95cb48b1dd76
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 642935
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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