Kobayashi America Manufacturing, LLCMay 27, 2022

FDA 483 - Kobayashi America Manufacturing, LLC - May 27, 2022

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Record Details

Kobayashi America Manufacturing, LLC, an own label distributor in Dalton, GA, was cited for significant deficiencies in its quality control unit's oversight of contract manufactured OTC drug products. The inspection revealed failures in batch record review, stability data evaluation for expiration dating, microbiological testing, complaint handling, temperature monitoring for storage, and labeling control. These issues indicate a lack of robust quality assurance for drug products.

Company: Kobayashi America Manufacturing, LLC
Inspection Date: May 27, 2022
Product Type: Drugs
Office: Atlanta District Office
Person: Lavalais Song (Strategic Communications Specialist, Consumer Safety Officer)

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ID · 92241cf8-bbaa-4898-b020-88b9650f1358