FDA Inspection 1027759 — Hemarus, LLC
The FDA completed an inspection of Hemarus, LLC on October 5, 2017 in Jacksonville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 5, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 9225 | 21 CFR 606.171 | Biological product deviation report |