Warning letter
COATS Aloe International Inc.: warning letter of May 1, 2001
FDA warning letter UCM069623 · Dallas District Office
Key facts
| Reference number | UCM069623 |
|---|---|
| Company | COATS Aloe International Inc. |
| Subject | CGMP for Finished Pharmaceuticals/Drug and Cosmetic Manufacturing Facility/Adulterated |
| Issue date | May 1, 2001 |
| Posted date | May 1, 2001 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.198, 21, 211, 211.25, 211.67, 211.82, 211.165, 211.166, 211.22(a), 211.22(b), 211.94(b), 211.110(a) and 2 more |
| Country | 3 |
| Inspection city | Dallas |
| Inspection ZIP | 75243-8315 |
| Inspection start date | Mar 12, 2001 |
| 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: