# FDA 483 - Azurity Pharmaceuticals, Inc. - February 24, 2022

Source: https://www.globalkeysolutions.net/records/483/azurity-pharmaceuticals-inc/2704437d-fff0-4d09-b5aa-59c63a5d39d3

> FDA 483 for Azurity Pharmaceuticals, Inc. on February 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Azurity Pharmaceuticals, Inc.
- Inspection Date: 2022-02-24
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Azurity Pharmaceuticals, Inc. in Wilmington, MA, identified significant deficiencies across three observations. The firm failed to adequately clean equipment, specifically a sampling booth, and lacked proper sampling procedures for active pharmaceutical ingredients. Additionally, the company did not verify cleaning validation for fill lines after introducing new products, indicating potential risks to drug product quality and purity.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/terry-bridgewater/59dfea35-4435-47b1-ac4a-0eb6eaf83bc8)
- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7