Warning letter
Kaylaan LLC: warning letter of Aug 19, 2024
FDA warning letter 681977 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 681977 |
|---|---|
| Company | Kaylaan LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Aug 19, 2024 |
| Posted date | Sep 3, 2024 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.58, 211.22(a), 211.25(a), 211.84(d)(1), 211.100(a), 211.165(a), 211.166(a), 211.180(e), 211.188(b) |
| Inspection city | Floral Park |
| Inspection ZIP | 11001 |
| Inspection start date | Feb 14, 2024 |
| Letter on fda.gov | fda.gov |
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: