Abbott LaboratoriesApril 1, 2009

FDA 483 - Abbott Laboratories - April 01, 2009

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Record Details

Abbott Nutrition in Columbus, OH was inspected regarding its infant formula manufacturing. The inspection revealed significant deficiencies in the firm's complaint handling procedures and its actual investigation of infant formula complaints, particularly concerning potential health hazards to infants. These issues indicate a failure to adequately investigate serious complaints involving multiple infants experiencing adverse symptoms.

Company: Abbott Laboratories
Inspection Date: April 1, 2009
Product Type: Other
Office: Cincinnati District Office
People: Rebecca Clancy
Leslie R. Clark
Phillip M. Pontikos (Realtor)

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ID · 3c5b7ee8-86d1-4808-a50c-8fdab0b1e77b