FDA Inspection 1328792 — Med-Mizer, Inc.
The FDA completed an inspection of Med-Mizer, Inc. on Jul 31, 2026 in Batesville, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 31, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Batesville, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23083 | ISO 13485:2016 Clause 6.4.2 | Arrangements for control of contaminated product not planned and documented |
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23168 | ISO 13485:2016 Clause 7.5.6 | Planned results not consistently met during validation of processes |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |