Drug factory · FDA FEI 2127022

Padagis US LLC

3940 Quebec Ave N, Minneapolis, MN, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 8, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

12 drug inspections on record since 2009: 5 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Chlorothiazide	Makes it	Salix Pharmaceuticals, Inc.	65649-311
Hydrocortisone	Makes it	Salix Pharmaceuticals, Inc.	65649-401, 65649-411, 65649-511
Triamcinolone Acetonide	Makes it	Padagis Israel Pharmaceuticals Ltd	45802-064

Ended	Result	Program	Problems noted
Apr 8, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	7
Sep 6, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jan 31, 2024	No problems found	Bioresearch Monitoring	—
May 5, 2023	No problems found	Bioresearch Monitoring	—
Feb 18, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	3
Oct 23, 2019	No problems found	Bioresearch Monitoring	—
Jul 7, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 6, 2013	No problems found	Drug Quality Assurance	—
Feb 6, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 6, 2013	No problems found	Bioresearch Monitoring	—
Nov 19, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	—
Mar 20, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Specifications - finished dietary supplement 21 CFR 111.70(e)
You did not establish product specifications for identity, strength and limits on contamination.
Scheduled process establishment 21 CFR 114.83
A scheduled process was not established by a qualified person who has expert knowledge acquired through appropriate training and experience in acidification and processing of acidified foods.
Hazard analysis - Identification of hazard 21 CFR 117.130(a)(1)
Your hazard analysis did not identify a hazard that required a preventive control.
Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that conform to appropriate standards of identity, strength, quality and purity.
Stability sample storage conditions described 21 CFR 211.166(a)(2)
The written stability program for drug products does not describe the storage conditions for samples retained for testing.
Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed.

Cleaning SOP/inspection 21 CFR 211.67(b)(6)
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.

Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the storage, handling and sampling of components.

Registered with FDA for: analysis; label; manufacture; pack.