Drug factory · FDA FEI 3000118564

Catalent Ontario Limited

2125 Ambassador Drive, Windsor, Canada

Problems found, fixed voluntarily at FDA's last inspection, Jan 20, 2023.

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

7 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Amantadine	Makes it and tests it	Upsher-Smith Laboratories, Inc.	0832-1015
Ascorbic Acid, Niacinamide, Pyridoxine Hydrochloride, Calcium Pantothenate, Thia	Makes it	Cypress Pharmaceutical, Inc.	60258-162
Calcium Cation and Iron	Makes it	Mission Pharmacal Company	0178-0797
Diclofenac	Makes it	Leading Pharma, LLC	69315-275

Ended	Result	Program	Problems noted
Jan 20, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	1
Feb 8, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jun 29, 2018	Serious problems, FDA action	Bioresearch Monitoring	—
Sep 18, 2015	No problems found	Drug Quality Assurance	—
Sep 6, 2013	No problems found	Drug Quality Assurance	—
Sep 16, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	4
Aug 14, 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.

Drug product reserve containers 21 CFR 211.170(b)
Drug product reserve samples are not stored in an immediate container-closure system that has essentially the same characteristics as the marketed product.

Specification description of sample/testing 21 CFR 211.160(b)(1)
The specifications for components, drug product containers or closures and labeling are deficient in that they do not include a description of the sampling plan.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and inspection of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review 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.
Top/Middle/Bottom container sampling 21 CFR 211.84(c)(4)
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
Component identity verification 21 CFR 211.84(d)(1)
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Registered with FDA for: analysis; manufacture.