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FDA Inspection
•Vitalant•June 27, 2010

Vitalant – FDA Inspection, Jun 27, 2010

Record Details

This FDA Inspection record concerns Vitalant, with an inspection on June 27, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Vitalant
Inspection Date
June 27, 2010
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · ac71aa7a-6688-4aeb-ab20-a0c1912aae95

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
670230
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.60(b)Equipment calibration frequency
  2. 21 CFR 606.171Biological product deviation report
  3. 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 Vitalant

5
DateClassificationOfficeProject area
April 30, 2025Not classifiedLos Angeles District Office
February 24, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
July 12, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 19, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 15, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Vitalant
  • FDA Inspection 1269240 - 2025-04-30
  • FDA Inspection 1163403 - 2022-02-24
  • FDA Inspection 1059991 - 2018-07-12
  • FDA Inspection 960998 - 2016-02-19
  • FDA Inspection 897348 - 2014-09-15

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