FDA inspection
Sharp Sterile Manufacturing, LLC: FDA inspection ending Jun 12, 2024
FDA inspection 1240940 · Voluntary Action Indicated (VAI) · Lee, MA
Key facts
| Inspection ID | 1240940 |
|---|---|
| Firm | Sharp Sterile Manufacturing, LLC |
| FEI number | 3012144557 |
| Address | 480 Pleasant St |
| City | Lee |
| State | MA |
| ZIP | 01238 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Jun 12, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
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
- 10–99 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