Warning letter
Colorado Histo-Prep: warning letter of Mar 11, 2014
FDA warning letter 420209 · Center for Drug Evaluation and Research
Key facts
| Reference number | 420209 |
|---|---|
| Company | Colorado Histo-Prep |
| Subject | Good Laboratory Practice (GLP) |
| Issue date | Mar 11, 2014 |
| Posted date | Apr 16, 2014 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 58, 58.35(a), 58.35(b)(5), 58.35(b)(6), 58.63(a), 58.81(a), 58.81(b)(10) |
| Inspection city | Fort Collins |
| Inspection ZIP | 80526-5556 |
| Inspection start date | Apr 10, 2013 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 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: