Drug factory · FDA FEI 3012763653
i3 Pharmaceuticals, LLC
200 Park Avenue, Warminster, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, May 22, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2018: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 22, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 22, 2024 | No problems found | Bioresearch Monitoring | — |
| Mar 3, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 21, 2018 | 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.
May 22, 2026 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 and fully followed. - 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 and cleaning and maintenance.
Registered with FDA for: analysis; label; manufacture; pack.