FDA Inspection
SonoCine Inc.SonoCine Inc. – FDA Inspection, Aug 16, 2019
Record Details
This FDA Inspection record concerns SonoCine Inc., with an inspection on August 16, 2019, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 1fc7fe82-4bb7-43d7-9498-4b21e878a9c2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1100095
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 812.2(b)Abbreviated requirements / non-significant risk study
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SonoCine Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SonoCine Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.