Warning letter
Genetech Inc: warning letter of Nov 29, 2018
FDA warning letter UCM628019 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM628019 |
|---|---|
| Company | Genetech Inc |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Nov 29, 2018 |
| Posted date | Nov 29, 2018 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.192, 312, 211.22(a), 211.42(c)(5), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.80(a), 211.84(a), 211.100(a), 211.113(b), 211.160(b), 211.166(a) and 19 more |
| Country | 3 |
| Inspection city | San Diego |
| Inspection ZIP | 92109 |
| Inspection start date | Jun 18, 2018 |
| Letter on fda.gov | web.archive.org |
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: