FDA Inspection
VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L)VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L) – FDA Inspection, Oct 8, 2014
Record Details
This FDA Inspection record concerns VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L), with an inspection on October 8, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 8, 2014
- Product Type
- Biologics
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ID · 6aba4272-c77a-4a83-b344-a2e8322715d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899023
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L)
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 1, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 18, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 16, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 11, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for VA Pittsburgh Health Care System Lab. Svc. Blood Bank (132L)
- FDA Inspection 1237861 - 2024-05-01
- FDA Inspection 1102306 - 2019-06-25
- FDA Inspection 992487 - 2016-10-18
- FDA Inspection 807124 - 2012-11-16
- FDA Inspection 709571 - 2011-02-11
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