# FDA 483 - Azurity Pharmaceuticals, Inc. - March 02, 2023

Source: https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/3a26f0be-61a2-41f0-9deb-51eead2d9a04

> FDA 483 for Azurity Pharmaceuticals, Inc. on March 02, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Azurity Pharmaceuticals, Inc.
- Inspection Date: 2023-03-02
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Azurity Pharmaceuticals, Inc. in Wilmington, MA, identified multiple significant deficiencies in quality control and manufacturing. The firm failed to thoroughly investigate consumer complaints regarding lead contamination and product crystallization, as well as the origin of an unknown impurity in Lansoprazole products. Additionally, the inspection revealed inadequate process validation, an insufficient stability program, and unvalidated analytical test methods.

## Related Documents

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- [483 - 2025-02-19](https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/fbd8eaca-fe0a-415e-8722-8c80ddd8f442)

## Related Officers

- [Robert J. Martin](https://www.globalkeysolutions.net/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.globalkeysolutions.net/companies/azurity-pharmaceuticals-inc/be6c2042-21df-4e44-a30d-11c6629303d8

Office: https://www.globalkeysolutions.net/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94