FDA inspection
Spectrum Medical Ltd.: FDA inspection ending Apr 27, 2023
FDA inspection 1204157 · Official Action Indicated (OAI) · Gloucester
Key facts
| Inspection ID | 1204157 |
|---|---|
| Firm | Spectrum Medical Ltd. |
| FEI number | 3006073153 |
| Address | Harrier 4, Meteor Business Park, Cheltenham Road East |
| City | Gloucester |
| Country | United Kingdom |
| Fiscal year | 2023 |
| Inspection end date | Apr 27, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 666543 |
At a glance
- 1–9 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