# Biolink Life Sciences Carolinas Inc. – FDA 483, Jul 2, 2026

Source: https://www.keypedia.com/records/483/biolink-life-sciences-carolinas-inc/b19fb6d9-6e51-4fd9-83a0-b143f2d440bd

> FDA 483 for Biolink Life Sciences Carolinas Inc. on July 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biolink Life Sciences Carolinas Inc.
- Inspection Date: 2026-07-02
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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.

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- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)
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Company: https://www.keypedia.com/companies/biolink-life-sciences-carolinas-inc/4dcd35f4-7c81-4716-9579-69ea1885de3e

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7