FDA inspection
Monserrat Pharmaceuticals Inc.: FDA inspection ending Jul 18, 2003
FDA inspection 284039 · Official Action Indicated (OAI) · Aguas Buenas, PR
Key facts
| Inspection ID | 284039 |
|---|---|
| Firm | Monserrat Pharmaceuticals Inc. |
| FEI number | 3004082470 |
| Address | 34 Calle Munoz Rivera |
| City | Aguas Buenas |
| State | PR |
| ZIP | 00703-3208 |
| Fiscal year | 2003 |
| Inspection end date | Jul 18, 2003 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | UCM146158 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes 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