FDA inspection
IBL Acquisitions LLC: FDA inspection ending Jan 18, 2018
FDA inspection 1038078 · Voluntary Action Indicated (VAI) · Indianapolis, IN
Key facts
| Inspection ID | 1038078 |
|---|---|
| Firm | IBL Acquisitions LLC |
| FEI number | 3008799671 |
| Address | 1504 Sadlier Circle South Dr |
| City | Indianapolis |
| State | IN |
| ZIP | 46239-1064 |
| Fiscal year | 2018 |
| Inspection end date | Jan 18, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Rad Cntrl & Hlth Safety Act (RCHSA) Auth|Radiation Control and Health Safety Act (RCHSA) Authority |
| Product type | Devices |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- No 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