1149738

Med-Mizer, Inc. — FEI 3004976058

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 6, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Batesville, IN (United States)

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
312321 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
316021 CFR 820.184Lack of or inadequate DHR procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
326421 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures