FDA inspection
PAR Sterile Products LLC: FDA inspection ending Aug 26, 2016
FDA inspection 987324 · Voluntary Action Indicated (VAI) · Rochester, MI
Key facts
| Inspection ID | 987324 |
|---|---|
| Firm | PAR Sterile Products LLC |
| FEI number | 1818977 |
| Address | 870 Parkdale Rd |
| City | Rochester |
| State | MI |
| ZIP | 48307-1740 |
| Fiscal year | 2016 |
| Inspection end date | Aug 26, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
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