FDA Inspection
Endotec, Inc.Endotec, Inc. – FDA Inspection, Oct 14, 2016
Record Details
This FDA Inspection record concerns Endotec, Inc., with an inspection on October 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 54db0071-85db-4bf7-a3e6-3ce002d87dfb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 991826
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Endotec, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2017 | OAI | 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 |
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