# FDA 483 - Azurity Pharmaceuticals, Inc. - January 15, 2020

Source: https://www.keypedia.com/records/483/azurity-pharmaceuticals-inc/5112db17-449d-4ac7-802d-0dd69b3bd25b

> FDA 483 for Azurity Pharmaceuticals, Inc. on January 15, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Azurity Pharmaceuticals, Inc.
- Inspection Date: 2020-01-15
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: CutisPharma, Inc. in Wilmington, MA, was inspected as a testing laboratory and received a Form 483 with two observations. The inspection revealed significant issues with the establishment of test method accuracy and equipment qualification, as well as a failure to thoroughly investigate customer complaints and unexplained discrepancies. These findings indicate deficiencies in quality control and complaint handling processes.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)

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

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