FDA Inspection
Greeley Emergency and Surgery CenterGreeley Emergency and Surgery Center – FDA Inspection, Nov 19, 2014
Record Details
This FDA Inspection record concerns Greeley Emergency and Surgery Center, with an inspection on November 19, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 19, 2014
- Product Type
- Biologics
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ID · ae13be31-0d0e-431c-9f82-92cdacae9237
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 909152
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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