FDA Inspection 1332842 — Entrotech Life Sciences, Inc.
The FDA completed an inspection of Entrotech Life Sciences, Inc. on Aug 17, 2026 in Columbus, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 17, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Columbus, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23098 | ISO 13485:2016 Clause 7.3.1 | Design and development procedures not documented |
| 23114 | ISO 13485:2016 Clause 7.3.6 | Design and development verification not performed |
| 23125 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not complete prior to release of product |