Drug factory · FDA FEI 1000117147

Actavis Laboratories UT, Inc.

577 Chipeta Way, Salt Lake City, UT, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 19, 2025.

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: 4 with no problems, 7 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Diclofenac	Labels it	Actavis Pharma, Inc.	0228-2551
Lidocaine	Makes it	PureTek Corporation	59088-396

Ended	Result	Program	Problems noted
Sep 19, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Mar 19, 2024	Serious problems, FDA action	Drug Quality Assurance	5
Aug 20, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	1
Aug 2, 2018	No problems found	Bioresearch Monitoring	—
Oct 25, 2017	No problems found	Drug Quality Assurance	—
Dec 8, 2015	No problems found	Drug Quality Assurance	—
Oct 17, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jan 17, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 14, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 8, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jan 14, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	4
Apr 24, 2009	No problems found	Drug Quality Assurance	—

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

Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not written.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.

Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
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.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules and instructions for protection of clean equipment from contamination prior to use.

Labels and labeling stored separately 21 CFR 211.122(d)
Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.

Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

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