FDA Inspection 729744 — Mego Afek AC Ltd.
The FDA completed an inspection of Mego Afek AC Ltd. on May 5, 2011 in Afek. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Afek (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |