Warning letter
Qualis, Inc.: warning letter of Jun 23, 2004
FDA warning letter UCM146462 · Kansas City District Office
Key facts
| Reference number | UCM146462 |
|---|---|
| Company | Qualis, Inc. |
| Subject | GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 23, 2004 |
| Posted date | Jun 23, 2004 |
| Issuing office | Kansas City District Office |
| Product type | Drugs |
| CFR sections cited | 210, 211.63, 211.80, 211.192, 211.22(d), 211.42(c), 211.42(c)(1), 211.42(c)(2), 211.100(a), 211.100(b), 211.165(d) |
| Country | 3 |
| Inspection city | Ankeny |
| Inspection ZIP | 50021-9405 |
| Inspection start date | Mar 22, 2004 |
| 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: