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FDA Inspection
•ALBA Bioscience Limited•September 14, 2018

ALBA Bioscience Limited – FDA Inspection, Sep 14, 2018

Record Details

This FDA Inspection record concerns ALBA Bioscience Limited, with an inspection on September 14, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
ALBA Bioscience Limited
Inspection Date
September 14, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Michele L. Forster (Investigator)
View Company Profile

ID · 2c06e954-68bf-4502-8570-9a39f6ed8f1a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1067742
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

Other FDA inspections of ALBA Bioscience Limited

7
DateClassificationOfficeProject area
May 25, 2017NAICenter for Devices and Radiological HealthCompliance: Devices
May 20, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 22, 2014VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 27, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 25, 2011VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for ALBA Bioscience Limited
  • FDA Inspection 1016480 - 2017-05-25
  • FDA Inspection 1007261 - 2016-05-20
  • FDA Inspection 896944 - 2014-09-22
  • FDA Inspection 801049 - 2012-04-27
  • FDA Inspection 714061 - 2011-02-25

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