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

Source: https://www.keypedia.com/records/483/pace-analytical-life-sciences-llc/b14311ac-5fe0-47ca-b5d4-b7f371acc3ed

> 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: New Jersey District Office
- Summary: Pace Analytical Life Sciences LLC, a control testing laboratory, was subject to an FDA inspection from July 7 to July 10, 2025. This inspection, a Pre-Approval Inspection for NDA-017651-SUPPL-81, Heparin Sodium Injection, USP, resulted in two significant observations documented in an FDA Form 483, indicating concerns with data integrity and system controls.

The first observation highlighted a failure to maintain adequate backup files for data. Specifically, data from a Nuclear Magnetic Resonance (NMR) instrument, crucial for drug substance identification testing, had not been backed up since June 6, 2025. The firm's risk assessment for a server/network switchover was found lacking a contingency plan for potential delays or failures in backup procedures.

The second observation noted insufficient controls over computer systems to ensure that changes to master production and control records are made exclusively by authorized personnel. The audit trail for the NMR instrument was deemed inadequate, failing to provide a detailed history of events including 'what happened, when events occurred, who was involved, and what actions were performed.' This raises questions about the thoroughness of audit trail reviews and the overall integrity of electronic data.

Pace Analytical Life Sciences LLC is required to promptly address these observations by developing and implementing robust corrective and preventive actions to ensure compliance with regulatory expectations for data management and system security.

## Related Documents

- [483 - 2025-07-10](https://www.keypedia.com/records/483/pace-analytical-life-sciences-llc/3517a1a0-a806-4081-a133-ff9ee57c03b3)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/cheri-voorhees-manager-commercial-quality-assurance-laboratory/aad3541d-a04f-4d55-845a-1f1cf546afd4)
- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)
- [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/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248