# FDA 483 - BioMed Laboratories, LLC. - October 31, 2025

Source: https://www.keypedia.com/records/483/biomed-laboratories-llc/be3f693e-4817-4bd7-a732-37001dcd4a3d

> FDA 483 for BioMed Laboratories, LLC. on October 31, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioMed Laboratories, LLC.
- Inspection Date: 2025-10-31
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: During an inspection, BioMed Laboratories, LLC. in Dallas, TX, was cited for significant deficiencies in its OTC drug manufacturing operations. The firm failed to establish and follow adequate procedures for stability testing, component control, quality unit responsibilities, and equipment cleaning. These issues indicate a lack of robust quality systems and control over drug product manufacturing.

## Related Officers

- [Mercedes N. Overton](https://www.keypedia.com/people/mercedes-n-overton/d3c24898-20d4-45f8-adda-24431066c9e6)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/biomed-laboratories-llc/edd6f3dd-0613-4139-ad51-86cbebace29e

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