FDA Inspection
Endotec, Inc.Endotec, Inc. – FDA Inspection, Dec 19, 2017
Record Details
This FDA Inspection record concerns Endotec, Inc., with an inspection on December 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 5429f8e3-54b2-4f9f-9087-08448aba21ad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1036515
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Endotec, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 7, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 19, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 29, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Endotec, 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.