FDA Inspection 953641 — Reading Hospital
The FDA completed an inspection of Reading Hospital on Dec 16, 2015 in West Reading, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 16, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Reading, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |
| 640 | 21 CFR 803.18(a) | Event files -- failure to establish and maintain |
| 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 |