# FDA 483 - Unette Corp - September 11, 2025

Source: https://www.keypedia.com/records/483/unette-corp/eeb6b433-4867-476e-9ac5-7b52a9507ac2

> FDA 483 for Unette Corp on September 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unette Corp
- Inspection Date: 2025-09-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)

Company: https://www.keypedia.com/companies/unette-corp/6c0ffc82-788a-4de1-8053-da1b5ff61ffb

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248