Warning letter
Aurolife Pharma, LLC: warning letter of Oct 16, 2020
FDA warning letter 607087 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 607087 |
|---|---|
| Company | Aurolife Pharma, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Oct 16, 2020 |
| Posted date | Nov 24, 2020 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.58, 211.192, 211.67(b), 211.100(a) |
| Inspection city | Dayton |
| Inspection ZIP | 08810-1519 |
| Inspection start date | Jan 13, 2020 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: