FDA Inspection 1158756 — Ultrasonic Services, Inc.
The FDA completed an inspection of Ultrasonic Services, Inc. on Dec 10, 2021 in Houston, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Houston, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |