FDA Inspection 1177105 — BODY VISION MEDICAL
The FDA completed an inspection of BODY VISION MEDICAL on Jul 28, 2022 in Herzliya. 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
- Jul 28, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Herzliya (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |