FDA Inspection
Entrotech Life Sciences, Inc.Entrotech Life Sciences, Inc. – FDA Inspection, Jul 1, 2024
Record Details
This FDA Inspection record concerns Entrotech Life Sciences, Inc., with an inspection on July 1, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d75f39c1-81bc-4c16-9b50-7fe1b117fc26
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1242772
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Entrotech Life Sciences, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 1062290 - 2018-08-15
- FDA Inspection 1028826 - 2017-10-04
- FDA Inspection 749797 - 2011-10-11
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