FDA Inspection 946919 — Applied Medical Resources Corp
The FDA completed an inspection of Applied Medical Resources Corp on October 14, 2015 in Rancho Santa Margarita, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 14, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rancho Santa Margarita, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3224 | 21 CFR 820.70(g)(2) | Periodic equipment inspection lack of or inadequate procedu |
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |