FDA Inspection 1164424 — Cryos International USA, LLC
The FDA completed an inspection of Cryos International USA, LLC on Mar 8, 2022 in Orlando, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 8, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |
| 12495 | 21 CFR 1271.85(d) | Retesting of semen donors |