Biolink Life Sciences Carolinas Inc. – FDA 483, Jul 2, 2026
Biolink Life Sciences Carolinas Inc. in Cary, NC, a contract laboratory, received a Form 483 with three observations during an FDA inspection. The firm was cited for inadequate computer system controls for HPLC testing, including shared log-ons and missing audit trails, which compromises data integrity. Additionally, the company failed to perform specific identity testing on incoming components like HPLC-grade water and lacked adequate procedures for equipment cleaning and maintenance, specifically regarding the quality monitoring of deionized water used for rinsing.
ID · b19fb6d9-6e51-4fd9-83a0-b143f2d440bd
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