Warning letter
Sitek Research Laboratories [ARCHIVED]: warning letter of May 21, 2009
FDA warning letter 57425 · Center for Drug Evaluation and Research
Key facts
| Reference number | 57425 |
|---|---|
| Company | Sitek Research Laboratories [ARCHIVED] |
| Subject | Good Laboratory Practice (GLP) |
| Issue date | May 21, 2009 |
| Posted date | May 21, 2009 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 58, 58.185, 58.204, 58.33(b), 58.35(b)(1), 58.35(b)(3), 58.35(b)(6), 58.63(a), 58.130(e), 58.185(a)(4), 58.185(a) |
| Inspection city | Rockville |
| Inspection ZIP | 20850-6276 |
| Inspection start date | Nov 18, 2008 |
| 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: