Warning letter
Institute for Human Gene Therapy: warning letter of Jul 3, 2000
FDA warning letter UCM068575 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM068575 |
|---|---|
| Company | Institute for Human Gene Therapy |
| Subject | GLP (Good Laboratory Practices) |
| Issue date | Jul 3, 2000 |
| Posted date | Jul 3, 2000 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 58, 58.31, 58.33, 58.35, 58.51, 58.81, 58.105, 58.107, 58.185, 58.190, 58.130(e) |
| Country | 3 |
| Inspection city | Philadelphia |
| Inspection ZIP | 19104-4205 |
| Inspection start date | Feb 14, 2000 |
| 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: