FDA Inspection 1234618 — Hemarus LLC
The FDA completed an inspection of Hemarus LLC on April 30, 2024 in Lauderhill, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 30, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lauderhill, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 121 | 21 CFR 606.121(c)(2) | Name, address, unique facility identifier |
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 157 | 21 CFR 606.160(d) | Retention period |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 18058 | 21 CFR 630.5(b)(2) | Responsible physician not on site |
| 18059 | 21 CFR 630.5(c)(1) | Improper delegation of activities - SP & plasmapheresis |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |