FDA Inspection 812190 — Hemagen Diagnostics Inc
The FDA completed an inspection of Hemagen Diagnostics Inc on December 20, 2012 in Baltimore, MD. 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
- December 20, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |