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483
•Abbott Laboratories•September 24, 2019

FDA 483 - Abbott Laboratories - September 24, 2019

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Record Details

An FDA inspection of Abbott Nutrition in Sturgis, MI, from September 16-24, 2019, revealed a significant issue regarding quality control. The firm failed to adequately test representative samples of powdered infant formula at the final product stage to ensure required microbiological quality standards were met. This indicates a serious lapse in ensuring product safety before distribution.

Company
Abbott Laboratories
Inspection Date
September 24, 2019
Product Type
Other
Office
Chicago District Office
People
  • Dariusz Galezowski (Consumer Safety Officer)
  • Daniel B. Arrecis (Investigator)
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ID · 58ecb2e4-0b47-4001-9c8a-caf28fa7836b

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