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

Source: https://www.globalkeysolutions.net/records/483/biolink-life-sciences-carolinas-inc/94ac826e-dad8-4aed-9499-3e4fe51f3831

> FDA 483 for Biolink Life Sciences Carolinas Inc. on July 21, 2025. 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: 2025-07-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.globalkeysolutions.net/companies/biolink-life-sciences-carolinas-inc/4dcd35f4-7c81-4716-9579-69ea1885de3e

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