Labverity
Facility profile

ANI Pharmaceuticals, Inc.

Drug product manufacturing · Packaging & labeling · Baudette, MN

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed2 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

LabelManufacturePack
Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Dec 6, 2024 · FDA documented observations for voluntary correction.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

Understand this record

Use the evidence, then ask for fit.

Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

Ask next

Ask what was corrected and review any later inspection or follow-up record.

Method and source details
View full inspection and compliance history13 inspection records

FDA inspection history

13 records, Jan 2010 – Dec 2024 · 6 NAI · 7 VAI · 0 OAI

DateClassProject areaCitationsFY
Dec 6, 2024VAIDrug Quality Assurance2025
Nov 18, 2022VAIDrug Quality Assurance2023
Apr 12, 2019NAIBioresearch Monitoring2019
Jul 28, 2016NAIDrug Quality AssuranceYes2016
Jul 28, 2016VAIBioresearch MonitoringYes2016
Sep 27, 2013VAIBioresearch Monitoring2013
Sep 27, 2013NAIDrug Quality Assurance2013
Jan 6, 2012VAIUnapproved and Misbranded Drugs2012
Sep 16, 2011VAIUnapproved and Misbranded Drugs2011
Sep 16, 2011NAIDrug Quality Assurance2011
Sep 15, 2011NAIDrug Quality Assurance2011
Jan 29, 2010VAIDrug Quality AssuranceYes2010
Jan 28, 2010NAIDrug Quality Assurance2010

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

Ask about services