908051
Applied Medical Resources Corp — FEI 2027111
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 16, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rancho Santa Margarita, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4192 | 21 CFR 806.10(a)(2) | Report of violation of the Act (see 803.52(e)(9)) |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |