FDA Inspection 1228542 — Integrity Medical Products Inc
The FDA completed an inspection of Integrity Medical Products Inc on Jan 22, 2024 in Farmers Branch, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Farmers Branch, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |