Brand-Nu Laboratories, Inc.November 22, 2021

FDA 483 - Brand-Nu Laboratories, Inc. - November 22, 2021

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Record Details

Brand-Nu Laboratories, LLC, an API/Excipient repacker in Meriden, Connecticut, was inspected by the FDA. The inspection revealed significant issues with the firm's quality control unit, specifically regarding the failure to follow written procedures for cleaning, environmental monitoring, and annual product reviews. Additionally, the firm failed to ensure employees received documented annual cGMP training.

Company: Brand-Nu Laboratories, Inc.
Inspection Date: November 22, 2021
Product Type: Drugs
Office: Division of Northeast Imports
Person: Samir C. Gala (Drug Investigator)

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ID · f2dac3ef-670a-47de-ba3e-3a94c71ac953