FDA inspection
Ortho Biologics, LLC: FDA inspection ending Jan 16, 2015
FDA inspection 910099 · Voluntary Action Indicated (VAI) · Manati, PR
Key facts
| Inspection ID | 910099 |
|---|---|
| Firm | Ortho Biologics, LLC |
| FEI number | 1000110299 |
| Address | Rd 2 Km 45.6 Bo Campo Alegre |
| City | Manati |
| State | PR |
| ZIP | 00674 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Jan 16, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None 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