FDA Inspection 1307694 — Gentuity, LLC
The FDA completed an inspection of Gentuity, LLC on March 5, 2026 in Sudbury, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sudbury, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23140 | ISO 13485:2016 Clause 7.4.1 | Supplier evaluation and selection criteria do not include required elements |
| 23151 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities are inadequate |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |