FDA inspection
Spectra Therapy, LLC.: FDA inspection ending Sep 13, 2024
FDA inspection 1229607 · Official Action Indicated (OAI) · Port Huron, MI
Key facts
| Inspection ID | 1229607 |
|---|---|
| Firm | Spectra Therapy, LLC. |
| FEI number | 3008539245 |
| Address | 3350 Lapeer Rd |
| City | Port Huron |
| State | MI |
| ZIP | 48060 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Sep 13, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 698026 |
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