Centaur IncFebruary 1, 2024

FDA 483 - Centaur Inc - February 01, 2024

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Record Details

Centaur Inc. in Olathe, KS, a drug manufacturer, received a Form 483 citing significant quality control deficiencies during an FDA inspection from January 29 to February 1, 2024. The firm failed to thoroughly investigate out-of-specification water system results and lacked proper sampling procedures, impacting the quality assurance of multiple drug product batches.

Company: Centaur Inc
Inspection Date: February 1, 2024
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Conner N. Mann (Consumer Safety Officer, FDA)

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ID · ad3ae69d-3424-4d98-a687-f45ff54d122f