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FDA Inspection
•BioLife Plasma Services, L.P.•December 13, 2018

BioLife Plasma Services, L.P. – FDA Inspection, Dec 13, 2018

Record Details

This FDA Inspection record concerns BioLife Plasma Services, L.P., with an inspection on December 13, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
BioLife Plasma Services, L.P.
Inspection Date
December 13, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Lewis K. Antwi (Issuing Officer)
View Company Profile

ID · 442d032d-2cda-40d9-a026-19b1f7fcb3d8

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1074336
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 606.160(a)(1)Concurrent documentation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of BioLife Plasma Services, L.P.

5
DateClassificationOfficeProject area
December 8, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 4, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 1, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 17, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 27, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for BioLife Plasma Services, L.P.
  • FDA Inspection 1001550 - 2016-12-08
  • FDA Inspection 912994 - 2015-02-04
  • FDA Inspection 816800 - 2013-02-01
  • FDA Inspection 705075 - 2010-12-17
  • FDA Inspection 573134 - 2009-03-27

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