483
Biolink Life Sciences Carolinas Inc.Biolink Life Sciences Carolinas Inc. – FDA 483, Jul 21, 2025
Record Details
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.
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ID · 94ac826e-dad8-4aed-9499-3e4fe51f3831
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