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

Source: https://www.globalkeysolutions.net/records/483/az-pharmaceutical-inc/8ffddd95-8feb-48e2-9952-0a3b71635f6f

> 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
- Summary: An FDA inspection of PENNER, conducted on September 22, 23, 24, and 26, 2025, resulted in the issuance of an FDA Form 483, detailing significant observations related to the firm's quality control unit and data integrity practices. The primary finding indicated that the responsibilities and procedures for the quality control unit were not adequately documented in writing or consistently followed.

Specifically, the firm's Quality Unit failed to establish a robust program for evaluating analytical data integrity within its laboratory operations. This deficiency manifested in several areas: Standard Operating Procedure (SOP) Number 115E.01, concerning the Quality Compliance Auditor job description, lacked specific responsibilities and instructions for verifying electronic analytical test data and conducting periodic system audit trail reviews to ensure data validity. Similarly, SOP Number 707.03, the "Laboratory Notebook & Logbook Documentation Guideline," did not define requirements for inspecting and evaluating periodic system audit trails. Furthermore, the existing analytical test data review process did not include comprehensive audit trail evaluations for data packages or full system audit trails, crucial for ensuring the integrity of test results throughout the analytical testing process.

These observations highlight non-compliance with the Federal Food, Drug, and Cosmetic Act, particularly regarding established quality system requirements. PENNER is therefore required to promptly address these noted deficiencies by revising and implementing comprehensive written procedures for its quality control unit, ensuring robust analytical data integrity evaluation, and verifying the validity of all laboratory test results through systematic audit trail reviews.

## Related Documents

- [483 - 2025-09-26](https://www.globalkeysolutions.net/records/483/az-pharmaceutical-inc/747a9a46-2274-4a1a-a1f2-f93fd5d149e2)

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