FDA inspection
Berkshire Sterile Manufacturing, LLC: FDA inspection ending May 23, 2022
FDA inspection 1170768 · Official Action Indicated (OAI) · Lee, MA
Key facts
| Inspection ID | 1170768 |
|---|---|
| Firm | Berkshire Sterile Manufacturing, LLC |
| FEI number | 3012144557 |
| Address | 480 Pleasant St |
| City | Lee |
| State | MA |
| ZIP | 01238-9265 |
| Fiscal year | 2022 |
| Inspection end date | May 23, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|Generic Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New Drug Evaluation|New 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