1161392

The Hygenic Company LLC. — FEI 1519375

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 17, 2021
Fiscal Year
2022
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Akron, OH (United States)

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
312121 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures