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FDA Inspection
•Plasma Services Group, Inc•March 15, 2018

Plasma Services Group, Inc – FDA Inspection, Mar 15, 2018

Record Details

This FDA Inspection record concerns Plasma Services Group, Inc, with an inspection on March 15, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Plasma Services Group, Inc
Inspection Date
March 15, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Bradley E. Benasutti
View Company Profile

ID · 7a2456ed-6cf1-40fa-9a1a-5a56922a4ce9

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1044808
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 606.121(c)(11)Required labeling information - manufacturing use
  2. 21 CFR 606.121(c)(4)(i)Expiration date
  3. 21 CFR 606.121(c)(1)Proper name of product
  4. 21 CFR 606.121(c)(12)Labeling; test results for rel transmitted infections

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Plasma Services Group, Inc

5
DateClassificationOfficeProject area
September 29, 2025NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 24, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 16, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 30, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 10, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Plasma Services Group, Inc
  • FDA Inspection 1293798 - 2025-09-29
  • FDA Inspection 1101877 - 2019-07-24
  • FDA Inspection 922805 - 2015-04-16
  • FDA Inspection 816767 - 2013-01-30
  • FDA Inspection 609902 - 2009-08-10

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