FDA inspection
CorneaGen - Boston: FDA inspection ending Dec 20, 2024
FDA inspection 1257221 · Waltham, MA
Key facts
| Inspection ID | 1257221 |
|---|---|
| Firm | CorneaGen - Boston |
| FEI number | 1000513310 |
| Address | 300 Bear Hill Rd Fl 2 |
| City | Waltham |
| State | MA |
| ZIP | 02451-1033 |
| Fiscal year | 2025 |
| Inspection end date | Dec 20, 2024 |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics, 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