Drug factory · FDA FEI 3017532195
Aarkish Pharmaceuticals NJ Inc
8 Commerce Road, Fairfield, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 24, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2022: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetazolamide | Makes it | Aarkish Pharmaceuticals NJ Inc. | 81005-104, 81005-105 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 24, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 18, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 24, 2025 inspection
- 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. - 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 intended use.
Registered with FDA for: analysis; label; manufacture; pack.