FDA Inspection
Rose Medical Center-Microbiology Center of ExcellenceRose Medical Center-Microbiology Center of Excellence – FDA Inspection, Feb 6, 2014
Record Details
This FDA Inspection record concerns Rose Medical Center-Microbiology Center of Excellence, with an inspection on February 6, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- February 6, 2014
- Product Type
- Biologics
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ID · 304f03e7-6789-436b-8700-fff82a2e3e1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865632
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 606.100(b)(10)Controlling storage temperatures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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