FDA inspection
Defibtech, LLC: FDA inspection ending Aug 18, 2010
FDA inspection 675878 · Official Action Indicated (OAI) · Guilford, CT
Key facts
| Inspection ID | 675878 |
|---|---|
| Firm | Defibtech, LLC |
| FEI number | 3003521780 |
| Address | 741 Boston Post Rd, Suite 201 |
| City | Guilford |
| State | CT |
| ZIP | 06437 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Aug 18, 2010 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 133290 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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