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FDA Inspection
•BioLife Plasma Services L.P.•August 25, 2017

BioLife Plasma Services L.P. – FDA Inspection, Aug 25, 2017

Record Details

This FDA Inspection record concerns BioLife Plasma Services L.P., with an inspection on August 25, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
BioLife Plasma Services L.P.
Inspection Date
August 25, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Lewis K. Antwi (Issuing Officer)
View Company Profile

ID · 0d84a17f-dcb9-4f90-84ef-7f3f8983d04f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1022840
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 630.10(g)(1)Proof Of Identity
  2. 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 BioLife Plasma Services L.P.

2
DateClassificationOfficeProject area
December 15, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 3, 2016Not classifiedDetroit District Office
Other documents for BioLife Plasma Services L.P.
  • FDA Inspection 1226505 - 2023-12-15
  • FDA Inspection 995589 - 2016-11-03

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