955862
Advocate Lutheran General Hospital — FEI 3005310193
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 11, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Park Ridge, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 621 | 21 CFR 803.11 | Failure to use FDA Form 3500A |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |
| 642 | 21 CFR 803.18(b)(1)(i) | Adverse events--all info not in file |
| 656 | 21 CFR 803.30(a)(1) | Report of Death Within 10 Days |
| 658 | 21 CFR 803.30(a)(2) | Report of Serious Injury Within 10 Days |
| 661 | 21 CFR 803.32 | Reporting All Information Reasonably Known |