FDA Inspection 1320202 — ITI Manufacturing, Inc.
The FDA completed an inspection of ITI Manufacturing, Inc. on June 3, 2026 in Sugar Land, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sugar Land, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |