Warning letter
Laboratorios Quantium LLC: warning letter of Feb 25, 2019
FDA warning letter 569146 · Center for Drug Evaluation and Research
Key facts
| Reference number | 569146 |
|---|---|
| Company | Laboratorios Quantium LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 25, 2019 |
| Posted date | Mar 12, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.128, 330.1(e), 211.137(a), 211.100(a), 211.84(a), 211.67(a), 211.22(a), 330.1, 211.34 |
| Inspection city | Medley |
| Inspection ZIP | 33166 |
| Inspection start date | May 16, 2018 |
| 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: