Warning letter
Qualgen: warning letter of Jun 3, 2016
FDA warning letter 495946 · Dallas District Office
Key facts
| Reference number | 495946 |
|---|---|
| Company | Qualgen |
| Subject | Unapproved New Drug/Compounding/Misbranding/Adulterated |
| Issue date | Jun 3, 2016 |
| Posted date | Jun 21, 2016 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 201.115, 211.192, 211.22(c), 211.42(c)(10)(iv), 211.100(a), 211.166(a) |
| Inspection city | Edmond |
| Inspection ZIP | 73013 |
| Inspection start date | Aug 24, 2015 |
| 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: