FDA Inspection
Plainview HospitalPlainview Hospital – FDA Inspection, Apr 11, 2012
Record Details
This FDA Inspection record concerns Plainview Hospital, with an inspection on April 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Plainview Hospital
- Inspection Date
- April 11, 2012
- Product Type
- Biologics
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ID · 3fd5b6a5-7932-4868-9d0b-220ad006bb51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776357
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.160(c)Assignment of donor number
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.100(b)(16)Labeling procedures to avoid labeling mix-ups
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Plainview Hospital
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 6, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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