Warning letter
Pinnacle Transplant Technologies, LLC: warning letter of Oct 1, 2024
FDA warning letter 646783 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 646783 |
|---|---|
| Company | Pinnacle Transplant Technologies, LLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Oct 1, 2024 |
| Posted date | Oct 22, 2024 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 211.192, 312, 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.67(a), 211.113(b), 211.160(b), 1271, 1271.15, 1271.10(a), 1271.10(a)(1), 1271.10(a)(2) and 2 more |
| Inspection city | Phoenix |
| Inspection ZIP | 85027 |
| Inspection start date | Aug 15, 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: