Warning letter
Clientele, Inc.: warning letter of Dec 3, 2020
FDA warning letter 607476 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 607476 |
|---|---|
| Company | Clientele, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 3, 2020 |
| Posted date | Dec 29, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 201.327(g), 211.22(a), 211.160(b), 211.100(a), 211.166(a), 201.66, 201.128, 211.34, 201.327(f) |
| Inspection city | Sunrise |
| Inspection ZIP | 33325 |
| Inspection start date | Feb 3, 2020 |
| Letter on fda.gov | fda.gov |
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: