# FDA 483 - Pace Analytical Life Sciences LLC - July 10, 2025

Source: https://www.keypedia.com/records/483/pace-analytical-life-sciences-llc/3517a1a0-a806-4081-a133-ff9ee57c03b3

> FDA 483 for Pace Analytical Life Sciences LLC on July 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pace Analytical Life Sciences LLC
- Inspection Date: 2025-07-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Pace Analytical Life Sciences LLC in Morrisville, NC, received a Form 483 with two observations during a pre-approval inspection for Heparin Sodium Injection, USP. The observations primarily concern deficiencies in computer system controls, specifically the failure to maintain data backups and inadequate audit trail functionality for a Nuclear Magnetic Resonance instrument used in drug substance identification testing. These issues indicate potential risks to data integrity and product quality.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/pace-analytical-life-sciences-llc/f3c41762-7cd2-4679-a06a-1b1a0e8ad3f1

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