FDA inspection
Helena Laboratories, Corp.: FDA inspection ending Jul 21, 2017
FDA inspection 1018711 · Official Action Indicated (OAI) · Beaumont, TX
Key facts
| Inspection ID | 1018711 |
|---|---|
| Firm | Helena Laboratories, Corp. |
| FEI number | 1618982 |
| Address | 1530 Lindbergh Dr |
| City | Beaumont |
| State | TX |
| ZIP | 77707 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Jul 21, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
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
- 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