FDA inspection
Ortho Biologics, LLC: FDA inspection ending Jan 20, 2004
FDA inspection 313600 · Voluntary Action Indicated (VAI) · Manati, PR
Key facts
| Inspection ID | 313600 |
|---|---|
| Firm | Ortho Biologics, LLC |
| FEI number | 1000110299 |
| Address | Rd 2 Km 45.6 Bo Campo Alegre |
| City | Manati |
| State | PR |
| ZIP | 00674 |
| Fiscal year | 2004 |
| Inspection end date | Jan 20, 2004 |
| 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
- Yes 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