FDA Inspection 1310382 — Midwest-Tek, Inc.
The FDA completed an inspection of Midwest-Tek, Inc. on April 1, 2026 in New Albany, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Albany, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23044 | ISO 13485:2016 Clause 4.2.5 | Procedures for control of records not documented |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |