# FDA 483 - Materials Characterization Center Inc - October 07, 2025

Source: https://www.keypedia.com/records/483/materials-characterization-center-inc/24777a0a-44b0-4cab-9cc8-5c2cbdaac72c

> FDA 483 for Materials Characterization Center Inc on October 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Materials Characterization Center Inc
- Inspection Date: 2025-10-07
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: An FDA inspection of Materials Characterization Center Inc in San Juan, PR, revealed significant deficiencies in computer system controls for laboratory analytical equipment. The firm failed to ensure that changes to records were instituted only by authorized personnel, lacking unique user access, audit trails, and proper privilege management for analytical software. These issues could compromise the integrity of drug product analysis data submitted to customers.

## Related Officers

- [Alan A. Rivera](https://www.keypedia.com/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.keypedia.com/companies/materials-characterization-center-inc/86cbd92b-5781-4040-b0e1-b568390e948e

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8