# FDA 483 - A&Z Pharmaceutical Inc - September 26, 2025

Source: https://www.keypedia.com/records/483/az-pharmaceutical-inc/747a9a46-2274-4a1a-a1f2-f93fd5d149e2

> FDA 483 for A&Z Pharmaceutical Inc on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: A&Z Pharmaceutical Inc
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: New York District Office
- Summary: A&Z Pharmaceutical Inc, a manufacturer in Hauppauge, NY, was cited for deficiencies in its quality control unit during an FDA inspection. The firm's quality unit failed to establish a robust analytical data integrity evaluation program, lacking specific responsibilities and procedures for verifying electronic data and conducting audit trail reviews. This indicates a significant concern regarding the validity of test results and data controls.

## Related Documents

- [483 - 2025-09-26](https://www.keypedia.com/records/483/az-pharmaceutical-inc/8ffddd95-8feb-48e2-9952-0a3b71635f6f)

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-o-hernandez/960bffbe-1b8e-41bc-b203-aee88d7d8dac)
- [Emmanuel T. Donyina](https://www.keypedia.com/people/emmanuel-t-donyina/a8f23469-487e-490d-bf02-41b2a60bb396)

Company: https://www.keypedia.com/companies/az-pharmaceutical-inc/118d2640-8828-43a5-a7fa-e62a67cd102b

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d