Warning letter
Scholzen Products Company Inc.: warning letter of Dec 12, 2000
FDA warning letter UCM078238 · Denver District Office
Key facts
| Reference number | UCM078238 |
|---|---|
| Company | Scholzen Products Company Inc. |
| Subject | GMP for Finished Pharmaceuticals/Gas & Liquid Medical Oxygen/Adulterated |
| Issue date | Dec 12, 2000 |
| Posted date | Dec 12, 2000 |
| Issuing office | Denver District Office |
| Product type | Drugs |
| CFR sections cited | 211.84(d), 211.84(d)(2), 211.100(a), 211.165(a), 211.142(a), 2, 21, 210, 211.22, 211.84, 211.160, 211.188 and 2 more |
| Country | 3 |
| Inspection city | Saint George |
| Inspection ZIP | 84770-3104 |
| Inspection start date | Aug 28, 2000 |
| 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: