Warning letter
Cryos International USA LLC: warning letter of Oct 24, 2022
FDA warning letter 639696 · Division of Biological Products Operations I
Key facts
| Reference number | 639696 |
|---|---|
| Company | Cryos International USA LLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Oct 24, 2022 |
| Posted date | Dec 6, 2022 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 1271, 1271.75, 1271.80, 1271.155, 1271.3(t), 1271.47(a), 1271.75(a)(1), 1271.3(r), 1271.3(r)(2), 1271.60(a), 1271.75(a), 1271.80(a) and 5 more |
| Inspection city | Orlando |
| Inspection ZIP | 32826 |
| Inspection start date | Feb 9, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: