FDA inspection
Genesis BPS, LLC.: FDA inspection ending Feb 11, 2013
FDA inspection 819283 · Official Action Indicated (OAI) · Mahwah, NJ
Key facts
| Inspection ID | 819283 |
|---|---|
| Firm | Genesis BPS, LLC. |
| FEI number | 1000527169 |
| Address | 465 Route 17 S |
| City | Mahwah |
| State | NJ |
| ZIP | 07430 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Feb 11, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 396662 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes 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