Unette CorpSeptember 11, 2025

FDA 483 - Unette Corp - September 11, 2025

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Record Details

Unette Corp, an OTC repackager in Randolph, NJ, received a Form 483 for significant quality control deficiencies. The firm failed to thoroughly investigate a high rejection rate of nearly 30% for leaking product packets, subsequently releasing the affected lot without proper review. Additionally, rejected materials were found improperly identified and segregated in the warehouse, indicating a lack of control over nonconforming products.

Company: Unette Corp
Inspection Date: September 11, 2025
Product Type: Drugs
Office: New Jersey District Office
Person: Michael O. Idowu (issuing_officer)

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ID · eeb6b433-4867-476e-9ac5-7b52a9507ac2