FDA Inspection 1333962 — Hemedex, Inc.
The FDA completed an inspection of Hemedex, Inc. on Aug 19, 2026 in Waltham, MA. 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 19, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Waltham, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23088 | ISO 13485:2016 Clause 7.1 | Records of risk management activities in product realization not maintained |
| 23119 | ISO 13485:2016 Clause 7.3.7 | Design and development validation not performed as planned |
| 23214 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures not documented |