# FDA 483 - Chemolee Lab Corporation - May 30, 2025

Source: https://www.keypedia.com/records/483/chemolee-lab-corporation/a6548b91-5c4b-47a8-be1b-1f2d2c42b749

> FDA 483 for Chemolee Lab Corporation on May 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chemolee Lab Corporation
- Inspection Date: 2025-05-30
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Chemolee Lab Corporation in Irving, TX, from May 19-30, 2025, revealed extensive deficiencies across its quality systems. The firm failed to establish an adequate Quality Unit, conduct proper annual product reviews, perform sufficient product testing and process validation, and maintain appropriate data integrity controls. These issues collectively indicate a severe lack of control over the manufacturing processes for their OTC drug products, compromising product quality and safety.

## Related Officers

- [Hala L. Selby](https://www.keypedia.com/people/hala-l-selby/4b507d3e-3d23-4c0c-97d4-495a25dc3947)
- [Rodney L. Tinzie](https://www.keypedia.com/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)

Company: https://www.keypedia.com/companies/chemolee-lab-corporation/e3c269ed-41e0-47d1-a09f-074a499f6846

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9