Warning letter
Pure Source LLC: warning letter of Feb 20, 2019
FDA warning letter 555240 · Dallas District Office
Key facts
| Reference number | 555240 |
|---|---|
| Company | Pure Source LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 20, 2019 |
| Posted date | Feb 26, 2019 |
| Issuing office | Dallas District Office |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.165(e), 207.1, 211.34, 211.100, 211.113, 211.100(b) |
| Inspection city | Doral |
| Inspection ZIP | 33172 |
| Inspection start date | Feb 8, 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: