# Biocentric Lab LLC – FDA 483, Jun 11, 2026

Source: https://www.keypedia.com/records/483/biocentric-lab-llc/e37509d4-d355-4d59-a383-764993d6fd7d

> FDA 483 for Biocentric Lab LLC on June 11, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biocentric Lab LLC
- Inspection Date: 2026-06-11
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: Biocentric Lab LLC, an HCT/P manufacturer in Grapevine, TX, was cited for significant deficiencies during an FDA inspection. Observations included failures in validating processes for amniotic membrane patches, not validating process changes, and failing to report HCT/P deviations to the FDA within the required timeframe. These issues indicate a lack of adequate controls over manufacturing processes and regulatory reporting for human tissue products.

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.keypedia.com/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

Company: https://www.keypedia.com/companies/biocentric-lab-llc/f0c1bd9e-5c9b-4bba-ae8a-af3815616c94

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