FDA inspection
MAK PHARMA USA LLC: FDA inspection ending Dec 30, 2024
FDA inspection 1257639 · Voluntary Action Indicated (VAI) · Randolph, NJ
Key facts
| Inspection ID | 1257639 |
|---|---|
| Firm | MAK PHARMA USA LLC |
| FEI number | 3017721405 |
| Address | 8 Middlebury Blvd |
| City | Randolph |
| State | NJ |
| ZIP | 07869 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Dec 30, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data