FDA establishment 3017452050, Berkeley Heights, New Jersey, United States. Part of Hikma Pharmaceuticals USA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
FY2018 to FY2027 to date; 0 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Jul 13, 2026 | Drugs · Bioresearch Monitoring | 1 cited reference
| Voluntary Action Indicated (VAI) |
| Product | Charges | Latest |
|---|---|---|
| ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC)Drugs · 60RCA18 | May 13, 2025 | |
| PHENYLEPHRINE HCL (ADRENERGIC)Drugs · 60CCK09 | Feb 12, 2024 | |
| GLYCOPYRROLATE (ANTI-CHOLINERGIC)Drugs · 61KCK22 | Feb 12, 2024 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters
Berkeley Heights, New Jersey, United States. Part of