Biocentric Lab LLC – FDA 483, Jun 11, 2026

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.