FDA Inspection 1047029 — Neomedix Corporation
The FDA completed an inspection of Neomedix Corporation on March 29, 2018 in Tustin, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tustin, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3138 | 21 CFR 820.130 | Packaging |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |