1152929

Sky Medical Supplies and Equipments, LLC — FEI 3011895419

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 17, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Parkland, FL (United States)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472221 CFR 820.40Procedures not adequately established or maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures