FDA Inspection 1020077 — Ziehm Imaging Inc.
The FDA completed an inspection of Ziehm Imaging Inc. on August 2, 2017 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 5907 | 21 CFR 1020.30(d)(1) | Report of assembly submitted within 15 days |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |