Drug factory · FDA FEI 3013433273

Aace Pharmaceuticals, Inc.

15 GARDNER ROAD, Fairfield, NJ, United States

Serious problems, FDA action at FDA's last inspection, Nov 22, 2024.

Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.

2 drug inspections on record since 2020: 0 with no problems, 1 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetaminophen and Butalbital	Makes it	Aarkish Pharmaceuticals NJ Inc.	81005-123
Methscopolamine	Makes it	i3 Pharmaceuticals, LLC	72319-029, 72319-030
Metolazone	Makes it	Aarkish Pharmaceuticals NJ Inc.	81005-124, 81005-125, 81005-126

Ended	Result	Program	Problems noted
Nov 22, 2024	Serious problems, FDA action	Drug Quality Assurance	4
Aug 10, 2020	Problems found, fixed voluntarily	Drug Quality Assurance	3

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

Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to approve and reject all drug products.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing and processing of a drug product are not maintained in a good state of repair.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not documented at the time of performance.
Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Equipment construction - reactive surfaces 21 CFR 211.65(a)
Equipment surfaces that contact in-process materials and drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.

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