Warning letter
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical: warning letter of Feb 21, 2018
FDA warning letter 546956 · Los Angeles District Office
Key facts
| Reference number | 546956 |
|---|---|
| Company | Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Feb 21, 2018 |
| Posted date | May 1, 2018 |
| Issuing office | Los Angeles District Office |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 200.10(b), 211.166(a), 211.167(a), 210.1(b), 201.115 |
| Inspection city | Los Angeles |
| Inspection ZIP | 90025-4650 |
| Inspection start date | Mar 13, 2017 |
| 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: