FDA Inspection 934491 — Cryos International USA, LLC
The FDA completed an inspection of Cryos International USA, LLC on Jul 15, 2015 in Orlando, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 15, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |