FDA Inspection
Plainview HospitalPlainview Hospital – FDA Inspection, Mar 18, 2014
Record Details
This FDA Inspection record concerns Plainview Hospital, with an inspection on March 18, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Plainview Hospital
- Inspection Date
- March 18, 2014
- Product Type
- Biologics
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ID · eb51ffad-bbcd-4bc0-be02-64e42fbe294b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 870510
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
8- 21 CFR 606.160(a)(2)Determination of lot numbers and supplies
- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 640.25(a)Storage temps./agitation
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 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 |
|---|---|---|---|
| April 11, 2012 | 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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