FDA Inspection 1317040 — Hemagen Diagnostics Inc
The FDA completed an inspection of Hemagen Diagnostics Inc on May 14, 2026 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 14, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23044 | ISO 13485:2016 Clause 4.2.5 | Procedures for control of records not documented |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |