# FDA 483 - Azurity Pharmaceuticals, Inc. - February 19, 2025

Source: https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/fbd8eaca-fe0a-415e-8722-8c80ddd8f442

> FDA 483 for Azurity Pharmaceuticals, Inc. on February 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Azurity Pharmaceuticals, Inc.
- Inspection Date: 2025-02-19
- Product Type: drugs
- Office Name: New England District Office
- Summary: Azurity Pharmaceuticals, Inc. in Wilmington, MA, was inspected and cited for deficiencies in its complaint handling procedures. The firm failed to ensure adequate investigations for drug product appearance issues, including a lack of retain sample examination by its contract manufacturer, which was approved by Azurity's Quality Assurance. This indicates a significant breakdown in quality control and complaint management.

## Related Documents

- [483 - 2020-01-15](https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/5112db17-449d-4ac7-802d-0dd69b3bd25b)
- [483 - 2022-02-24](https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/2704437d-fff0-4d09-b5aa-59c63a5d39d3)
- [483 - 2023-03-02](https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/3a26f0be-61a2-41f0-9deb-51eead2d9a04)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Armen H. Youssoufian](https://www.globalkeysolutions.net/people/armen-h-youssoufian/47aa0283-ca67-4aec-8ac1-7d4cb222eb04)

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

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144