Warning letter
Johnson & Johnson Pharmaceutical Research & Development, LLC: warning letter of Aug 10, 2009
FDA warning letter 64044 · Center for Drug Evaluation and Research
Key facts
| Reference number | 64044 |
|---|---|
| Company | Johnson & Johnson Pharmaceutical Research & Development, LLC |
| Subject | Sponsor/Monitor/Contract Research Organization |
| Issue date | Aug 10, 2009 |
| Posted date | Aug 10, 2009 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 312.50, 312.53(a), 312.56(b) |
| Inspection city | Raritan |
| Inspection ZIP | 08869 |
| Inspection start date | Apr 3, 2009 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: