1256216

MEDICREATIONS LLC — FEI 3012772112

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 20, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Compliance: Devices
Location
Las Vegas, NV (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
2279521 CFR 801.20(a)Label to bear a unique device identifier
2280021 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
310221 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313921 CFR 820.140Lack of or inadequate procedures for handling
315921 CFR 820.184DHR content
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
334521 CFR 820.200(a)Servicing - Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements