FDA inspection
Berkshire Sterile Manufacturing, Inc.: FDA inspection ending Oct 10, 2018
FDA inspection 1068306 · Voluntary Action Indicated (VAI) · Lee, MA
Key facts
| Inspection ID | 1068306 |
|---|---|
| Firm | Berkshire Sterile Manufacturing, Inc. |
| FEI number | 3012144557 |
| Address | 480 Pleasant St |
| City | Lee |
| State | MA |
| ZIP | 01238-9265 |
| Fiscal year | 2019 |
| Inspection end date | Oct 10, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Generic Drug Evaluation |
| 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
- 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