FDA Inspection
Entrotech Life Sciences, Inc.Entrotech Life Sciences, Inc. – FDA Inspection, Aug 17, 2026
Record Details
This FDA Inspection record concerns Entrotech Life Sciences, Inc., with an inspection on August 17, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Inspection Date
- August 17, 2026
- Product Type
- Medical Devices & Rad Health
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ID · e2deb077-fa0d-4b06-80ac-2f8eb5eefe4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1332842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.3.1Design and development procedures not documented
- ISO 13485:2016 Clause 7.3.6Design and development verification not performed
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Entrotech Life Sciences, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 15, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 4, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 11, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Entrotech Life Sciences, Inc.
- FDA Inspection 1242772 - 2024-07-01
- FDA Inspection 1062290 - 2018-08-15
- FDA Inspection 1028826 - 2017-10-04
- FDA Inspection 749797 - 2011-10-11
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