FDA inspection
Implant Direct Sybron Manufacturing LLC: FDA inspection ending Dec 2, 2019
FDA inspection 1111746 · Official Action Indicated (OAI) · Westlake Village, CA
Key facts
| Inspection ID | 1111746 |
|---|---|
| Firm | Implant Direct Sybron Manufacturing LLC |
| FEI number | 3001617766 |
| Address | 3050 E Hillcrest Dr |
| City | Westlake Village |
| State | CA |
| ZIP | 91362 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Dec 2, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: 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
- 10–99 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