1216090

Falck Medical Incorporated — FEI 3003156974

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 21, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Mystic, CT (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements