1280390

Pharmacaribe, LLC — FEI 3006500694

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 20, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Punta Gorda, FL (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
333121 CFR 820.181DMR - not or inadequately maintained
341521 CFR 820.22Quality Audit/Reaudit - conducted
366821 CFR 820.20(c)Management review dates
369621 CFR 820.100(b)Documentation
41921 CFR 820.20(b)Lack of or inadequate organizational structure