# FDA 483 - Bio-Medical Pharmaceutical Manufacturing Corporation - August 29, 2025

Source: https://www.globalkeysolutions.net/records/483/bio-medical-pharmaceutical-manufacturing-corporation/2c576cf8-6559-4b8f-9bc3-66e403329073

> FDA 483 for Bio-Medical Pharmaceutical Manufacturing Corporation on August 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Medical Pharmaceutical Manufacturing Corporation
- Inspection Date: 2025-08-29
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Bio-Medical Pharmaceutical Manufacturing Corporation in Houston, TX, revealed critical deficiencies in its OTC drug manufacturing operations. The firm failed to establish validated sterilization processes for an ophthalmic product, exhibited inadequate quality control oversight, and demonstrated widespread non-compliance in equipment cleaning, maintenance, and environmental controls. These issues indicate significant deviations from cGMP, raising concerns about the quality and safety of their drug products.

## Related Documents

- [483 - 2020-01-23](https://www.globalkeysolutions.net/records/483/bio-medical-pharmaceutical-manufacturing-corporation/c33d89af-4d4c-44bc-81ac-912d40d13f26)
- [WARNING_LETTER - 2025-08-29](https://www.globalkeysolutions.net/records/warning_letter/bio-medical-pharmaceutical-manufacturing-corporation/c3f49883-6cdd-4757-8d03-40ec8016fdd0)

## Related Officers

- [Director of Compliance Branch](https://www.globalkeysolutions.net/people/ronda-r-lloyd-jones/1446ba41-f1f2-4d40-8902-021b2bef3a53)
- [Milton J. De Jesus Tavarez](https://www.globalkeysolutions.net/people/milton-j-de-jesus-tavarez/24d4ed81-7c7e-42d2-8888-1c56c25eec67)

Company: https://www.globalkeysolutions.net/companies/bio-medical-pharmaceutical-manufacturing-corporation/ff03af78-b7e9-4d7f-97ba-78089c6ee119

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