Warning letter
Axium Healthcare Pharmacy dba Balanced Solutions Compounding: warning letter of Jul 16, 2013
FDA warning letter 398423 · Florida District Office
Key facts
| Reference number | 398423 |
|---|---|
| Company | Axium Healthcare Pharmacy dba Balanced Solutions Compounding |
| Subject | New Drug/Labeling/Adulterated/Misbranded |
| Issue date | Jul 16, 2013 |
| Posted date | Jul 16, 2013 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 211.165(f), 211.137(a), 201.115, 211, 211.28(a), 211.42(c)(10)(iv), 211.67(a), 211.113(b), 211.167(a) |
| Inspection city | Lake Mary |
| Inspection ZIP | 32746 |
| Inspection start date | Mar 12, 2013 |
| Letter on fda.gov | web.archive.org |
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: