Drug factory · FDA FEI 3010164738

AptaPharma Inc.

1533 Union Avenue, Pennsauken, NJ, United States

Problems found, fixed voluntarily at FDA's last inspection, Aug 14, 2026.

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

5 drug inspections on record since 2014: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Aminocaproic Acid	Makes it	Florida Pharmaceutical Products, LLC.	71921-175
Dexamethasone	Makes it	Kanchan Healthcare Inc	85742-004
Fluoxetine	Makes it	Upsher-Smith Laboratories, Inc.	0832-6032
Nystatin	Makes it	Kanchan Healthcare Inc	85742-013
Oseltamivir Acid	Makes it	Cipla USA., Inc., Exelan Pharmaceuticals, Inc.	69097-904, 76282-739
Sildenafil	Makes it	Novadoz Pharmaceuticals LLC	72205-035

Ended	Result	Program	Problems noted
Aug 14, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Oct 24, 2024	No problems found	Bioresearch Monitoring	—
Sep 25, 2019	No problems found	Drug Quality Assurance	—
Mar 16, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 23, 2014	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.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include specific test methods.

Registered with FDA for: manufacture; relabel; repack.