483
Abbott LaboratoriesAbbott Laboratories – FDA 483, Sep 24, 2019
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.
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ID · 58ecb2e4-0b47-4001-9c8a-caf28fa7836b
Violation Codes4
FD&C Act 801(a)(3)21 U.S.C. 350a(d)(1)21 CFR 106.55(g)(1)21 CFR 106.92(b)
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