FDA Inspection 1314396 — Pensar Medical
The FDA completed an inspection of Pensar Medical on Apr 28, 2026 in Houston, TX. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 28, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23109 | ISO 13485:2016 Clause 7.3.4 | Records of design and development outputs not maintained |
| 23118 | ISO 13485:2016 Clause 7.3.6 | Records of design and development verification not maintained |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 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 |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |