FDA Inspection
Endo-Therapeutics, Inc.Endo-Therapeutics, Inc. – FDA Inspection, Feb 7, 2017
Record Details
This FDA Inspection record concerns Endo-Therapeutics, Inc., with an inspection on February 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · e5c5caf9-825b-4579-a017-b19273f40af8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000402
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Endo-Therapeutics, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 22, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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