FDA Inspection 656914 — Medical Illumination International, Inc
The FDA completed an inspection of Medical Illumination International, Inc on March 31, 2010 in Chatsworth, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 31, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |