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FDA Inspection
•Alk-abello, Inc.•December 21, 2016

Alk-abello, Inc. – FDA Inspection, Dec 21, 2016

Record Details

This FDA Inspection record concerns Alk-abello, Inc., with an inspection on December 21, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Alk-abello, Inc.
Inspection Date
December 21, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Burnell M. Henry (FDA Associated Person)
View Company Profile

ID · 038248c7-1ba2-490a-b510-a8b33de94f47

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1002541
FDA center
Biologics
Project area
Vaccines and Allergenic Products
Outcome
Form 483 issued

Other FDA inspections of Alk-abello, Inc.

7
DateClassificationOfficeProject area
September 23, 2026Not classifiedNew York District OfficeVaccines and Allergenic Products
October 17, 2023VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
March 9, 2023VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
October 30, 2018VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
February 25, 2014VAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
View all 7 other inspections on the company page
Other documents for Alk-abello, Inc.
  • FDA Inspection 1323588 - 2026-09-23
  • FDA Inspection 1220460 - 2023-10-17
  • FDA Inspection 1202393 - 2023-03-09
  • FDA Inspection 1070323 - 2018-10-30
  • FDA Inspection 871138 - 2014-02-25

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