FDA Inspection
BioLife Plasma ServicesBioLife Plasma Services – FDA Inspection, Jun 2, 2010
Record Details
This FDA Inspection record concerns BioLife Plasma Services, with an inspection on June 2, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- BioLife Plasma Services
- Inspection Date
- June 2, 2010
- Product Type
- Biologics
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ID · 6a87a398-9079-43b1-b4b1-31ad7670a257
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 666770
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.63(d)Unreliable answers
- 21 CFR 630.40(b)(3)Results of testing
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of BioLife Plasma Services
6| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 17, 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 |
| March 24, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 11, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for BioLife Plasma Services
- FDA Inspection 1261469 - 2025-01-30
- FDA Inspection 1090778 - 2019-05-17
- FDA Inspection 990230 - 2016-10-18
- FDA Inspection 920248 - 2015-03-24
- FDA Inspection 832021 - 2013-04-11
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