FDA inspection
Clongen Laboratories LLC: FDA inspection ending Jun 17, 2025
FDA inspection 1278034 · Gaithersburg, MD
Key facts
| Inspection ID | 1278034 |
|---|---|
| Firm | Clongen Laboratories LLC |
| FEI number | 3006579817 |
| Address | 211 Perry Pkwy Ste 6 |
| City | Gaithersburg |
| State | MD |
| ZIP | 20877-2144 |
| Fiscal year | 2025 |
| Inspection end date | Jun 17, 2025 |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, Drugs |
At a glance
- None 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