FDA Inspection
V A Medical Center ErieV A Medical Center Erie – FDA Inspection, Mar 31, 2015
Record Details
This FDA Inspection record concerns V A Medical Center Erie, with an inspection on March 31, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- V A Medical Center Erie
- Inspection Date
- March 31, 2015
- Product Type
- Biologics
View Company Profile
ID · 4cb6fd7d-3b20-4edf-a9cf-45c24a77331f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920484
- 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)Concurrent documentation
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of V A Medical Center Erie
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 12, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 18, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 22, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 19, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for V A Medical Center Erie
- FDA Inspection 1252937 - 2024-10-16
- FDA Inspection 1094024 - 2019-06-12
- FDA Inspection 1014332 - 2017-05-18
- FDA Inspection 804856 - 2012-10-22
- FDA Inspection 695398 - 2010-10-19
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