FDA Inspection
Entrotech Life Sciences, Inc.Entrotech Life Sciences, Inc. – FDA Inspection, Aug 15, 2018
Record Details
This FDA Inspection record concerns Entrotech Life Sciences, Inc., with an inspection on August 15, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · db10a2c7-cc9d-448a-89e0-3ae6dc59bd45
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1062290
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Entrotech Life Sciences, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 1, 2024 | VAI | Center for Devices and Radiological Health | Compliance: 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 1028826 - 2017-10-04
- FDA Inspection 749797 - 2011-10-11
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