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483
•Abbott Laboratories•October 22, 2010

Abbott Laboratories – FDA 483, Oct 22, 2010

Record Details

Abbott Nutrition in Sturgis, MI, was cited for significant issues related to contamination control and pest exclusion during an FDA inspection. Observations included defective equipment design allowing beetles into the product stream, a long-standing failure to control warehouse and flour beetle infestations, and the presence of metal fragments in raw materials used for infant formula. These findings indicate serious deficiencies in maintaining sanitary conditions and product integrity.

Company
Abbott Laboratories
Inspection date
October 22, 2010
Product type
other
Office
Division of Pharmaceutical Quality Operations III
People
  • Erin Miller (Retail Food Specialist )
  • Tonnie L. Carter (Investigator)
View Company Profile

ID · 4ebcc33e-e611-4edd-a3b8-a95b050f6a06

Violation Codes1
21 CFR 331(c)

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Other documents for Abbott Laboratories
  • 483 - 2022-12-16December 16, 2022
  • 483 - 2022-03-18March 18, 2022
  • 483 - 2021-09-24September 24, 2021
  • EIR - 2021-09-24September 24, 2021
  • AMENDED_483 - 2021-09-20September 20, 2021

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