Drug factory · FDA FEI 3003194604

Actavis Laboratories FL, Inc.

4955 Orange Drive, Davie, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Nov 18, 2025.

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

9 drug inspections on record since 2009: 0 with no problems, 7 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Diclofenac and Misoprostol	Makes it, tests it and packages it	BluePoint Laboratories.	68001-231, 68001-232

Ended	Result	Program	Problems noted
Nov 18, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
May 25, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	5
Jan 17, 2020	Serious problems, FDA action	Drug Quality Assurance	—
Jul 19, 2018	Serious problems, FDA action	Drug Quality Assurance	—
Nov 28, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 15, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 20, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 25, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 4, 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.

Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

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.
Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions and sampling and testing procedures.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product.

Registered with FDA for: analysis; manufacture; pack.