Home / Facilities / 3003395329

Azurity Pharmaceuticals, Inc. — FDA Facility Profile

FEI 3003395329

Azurity Pharmaceuticals, Inc. is an FDA-inspected facility (FEI 3003395329) located in Woburn, MA, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

Reviewing Azurity Pharmaceuticals, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Azurity Pharmaceuticals, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

What FDA found at this site

Latest inspection: Dec 12, 2025: No Action Indicated (NAI)
Inspections on record: 6 (2 VAI, 4 NAI)
Last OAI inspection: None on record
Warning letters: 1 listed by FDA for this FEI, latest Sep 20, 2024
Recalls as the recalling firm: 5, latest Jan 4, 2024

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Dec 12, 2025	No Action Indicated (NAI)	No citations listed
Feb 24, 2022	Voluntary Action Indicated (VAI)	Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Cleaning SOPs/equipment protection (21 CFR 211.67(b)(5)) Top/Middle/Bottom container sampling (21 CFR 211.84(c)(4))
Jul 26, 2019	No Action Indicated (NAI)	No citations listed
Apr 19, 2016	No Action Indicated (NAI)	No citations listed
Jan 29, 2014	Voluntary Action Indicated (VAI)	No citations listed
Mar 19, 2010	No Action Indicated (NAI)	Document review, approval by designated individual (21 CFR 820.40(a))

Warning letters

Letters whose text states this FEI. Many letters do not state one, so this list can be incomplete: search warning letters by company name.

Sep 20, 2024: CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug. Read the letter on FDA.gov. FDA closed it out on Mar 3, 2026.

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Jan 4, 2024	Class I	D-0323-2024	Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only… Labeling: Label Mix-up
Dec 8, 2023	Class III	D-0213-2024	Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for… Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during…
Feb 15, 2023	Class II	D-0489-2023	Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL… cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Aug 24, 2021	Class I	D-0003-2022	Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit… Product Mix-up: Incorrect diluent component included in the kit.
Oct 20, 2016	Class III	D-0138-2017	FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only… and 1 more product Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as…

Facility details

Company: Azurity Pharmaceuticals, Inc.
Location: Woburn, MA (US)
Source: inspections