FDA Inspection 1120616 — Hemarus, LLC
The FDA completed an inspection of Hemarus, LLC on March 12, 2020 in Jacksonville, 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |