FDA Inspection
Mid America Clinical Laboratories St. Vincent Women's Hosp.Mid America Clinical Laboratories St. Vincent Women's Hosp. – FDA Inspection, Nov 28, 2016
Record Details
This FDA Inspection record concerns Mid America Clinical Laboratories St. Vincent Women's Hosp., with an inspection on November 28, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 28, 2016
- Product Type
- Biologics
- People
- Brittany M. Lowe (Issuing Officer)
- Lewis K. Antwi (Issuing Officer)
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ID · dbfe97f9-3265-493b-a5d0-f6dd931e6085
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994379
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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