FDA Inspection
Enterix, Inc.Enterix, Inc. – FDA Inspection, Mar 10, 2023
Record Details
This FDA Inspection record concerns Enterix, Inc., with an inspection on March 10, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 71ff7d28-02c3-4cd6-9210-4000ccacf182
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1199942
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Enterix, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 10, 2026 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 18, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 27, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 1, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Enterix, Inc.
- FDA Inspection 1330540 - 2026-08-10
- FDA Inspection 983532 - 2016-08-18
- FDA Inspection 808178 - 2012-11-27
- FDA Inspection 670927 - 2010-07-01
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