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•United States

Azurity Pharmaceuticals, Inc., Wilmington, MA – FDA Inspections

Inspection records and compliance data for Azurity Pharmaceuticals, Inc. in Wilmington, Massachusetts. 9 FDA inspections on record, 2 Form 483s, last inspected December 12, 2025.

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Company Profile

This profile covers Azurity Pharmaceuticals, Inc. based in Wilmington, Massachusetts, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
2
NAI
4
Unclassified
3
Form 483s
2
Warning letters
0

First inspected March 19, 2010. Last inspected December 12, 2025.

Most cited issue areas

  • Absence of Written Procedures1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Cleaning SOPs/equipment protection1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
December 12, 2025NAIHuman Drugs · Drug Quality Assurance1297348
February 19, 2025Not classifiedHuman Drugs · Drug Quality Assurance1261303
March 2, 2023Not classifiedHuman Drugs · Drug Quality Assurance1199279
February 24, 2022VAIHuman Drugs · Drug Quality Assurance1163010
July 26, 2019NAIHuman Drugs · Drug Quality Assurance1100022
December 20, 2017Not classifiedHuman Drugs1038444
April 19, 2016NAIHuman Drugs · Drug Quality Assurance970690
January 29, 2014VAIHuman Drugs · Bioresearch Monitoring865746
March 19, 2010NAIHuman Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices655593
FDA documents

Form 483s (4)

  • Form 483s · February 19, 2025
  • Form 483s · March 2, 2023
  • Form 483s · February 24, 2022
  • Form 483s · January 15, 2020

EIRs (2)

  • EIRs · December 22, 2019
  • EIRs · April 19, 2016
People (4)
John P. Mistler
Person
Dien Nguyen
Person
Christopher Janik
Person
Erik W. Koester
Person
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Boston University National Emerging Infectious Disease Laboratories
Company Information

Name

Azurity Pharmaceuticals, Inc.

FEI Number

3003395329

Address

841 Woburn St, Wilmington, Massachusetts 01887, United States

Country

United States

ID: be6c2042-21df-4e44-a30d-11c6629303d8

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