Warning letter
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy: warning letter of Feb 3, 2016
FDA warning letter 478447 · Florida District Office
Key facts
| Reference number | 478447 |
|---|---|
| Company | Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 3, 2016 |
| Posted date | Feb 23, 2016 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 211.165(a), 201.115, 211, 211.28(a), 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.113(b), 211.166(a), 211.167(a) |
| Inspection city | Fort Myers |
| Inspection ZIP | 33907 |
| Inspection start date | Dec 1, 2014 |
| 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: