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FDA Inspection
•Greater Metropolitan Community Blood Service Inc.•August 31, 2018

Greater Metropolitan Community Blood Service Inc. – FDA Inspection, Aug 31, 2018

Record Details

This FDA Inspection record concerns Greater Metropolitan Community Blood Service Inc., with an inspection on August 31, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Greater Metropolitan Community Blood Service Inc.
Inspection Date
August 31, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Irina Gaberman (FDA Associated Person)
View Company Profile

ID · 545ddc16-8e84-47f1-b0fc-22a2cf03a0e1

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1064397
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 606.160(a)(1)Concurrent documentation
  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 Greater Metropolitan Community Blood Service Inc.

6
DateClassificationOfficeProject area
March 11, 2026NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 14, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 5, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 16, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 24, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Greater Metropolitan Community Blood Service Inc.
  • FDA Inspection 1310512 - 2026-03-11
  • FDA Inspection 1194098 - 2022-12-14
  • FDA Inspection 947400 - 2015-11-05
  • FDA Inspection 858069 - 2013-12-16
  • FDA Inspection 764160 - 2012-01-24

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