# FDA 483 - Pharmaceutical Research Associates, Inc. - September 26, 2025

Source: https://www.keypedia.com/records/483/pharmaceutical-research-associates-inc/d797852a-ba4f-4107-9eab-411a40fe456e

> FDA 483 for Pharmaceutical Research Associates, Inc. on September 26, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmaceutical Research Associates, Inc.
- Inspection Date: 2025-09-26
- Product Type: other
- Office Name: Kansas City District Office
- Summary: Pharmaceutical Research Associates, Inc. in Lenexa, KS, a nonclinical laboratory, was issued a Form 483 following an inspection. The observations primarily concern deficiencies in document storage, archiving practices, and the maintenance of study records. Issues included inadequate environmental monitoring for archived GLP studies, delayed archiving of study data, and incomplete master schedule sheets.

## Related Officers

- [investigator](https://www.keypedia.com/people/chelsea-w-lamm/d7a8dd67-dc26-4c8a-8e3c-aebc267cb775)

Company: https://www.keypedia.com/companies/pharmaceutical-research-associates-inc/2642522f-3ac0-48db-bb7b-46c8ec54637e

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79