FDA Inspection 1001720 — Organ Recovery Systems, Inc.
The FDA completed an inspection of Organ Recovery Systems, Inc. on February 10, 2017 in Itasca, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 10, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Itasca, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |