FDA 483 - Biolink Life Sciences Carolinas Inc. - July 21, 2025

Biolink Life Sciences Carolinas Inc. in Cary, NC, a laboratory, was cited for significant deficiencies during an FDA inspection. Observations included failures to follow Quality Unit procedures, maintain complete laboratory records due to inaccessible data from a decommissioned server, and adequately qualify critical laboratory equipment. These issues collectively compromise data integrity and the reliability of analytical results for drug substance batch release.