FDA inspection
Bionike Incorporated: FDA inspection ending Dec 7, 1999
FDA inspection 7525 · Official Action Indicated (OAI) · Brisbane, CA
Key facts
| Inspection ID | 7525 |
|---|---|
| Firm | Bionike Incorporated |
| FEI number | 1000523183 |
| Address | 100 N Hill Dr Ste 35 |
| City | Brisbane |
| State | CA |
| ZIP | 94005-1012 |
| Fiscal year | 2000 |
| Inspection end date | Dec 7, 1999 |
| Classification | Official Action Indicated (OAI) |
| Project area | Product Evaluation: Med Devices |
| Product type | Devices |
At a glance
- None 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