FDA Inspection 935453 — H & A Mui Enterprises, Inc.

H & A Mui Enterprises, Inc. — FEI 3002807135

The FDA completed an inspection of H & A Mui Enterprises, Inc. on July 23, 2015 in Mississauga. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 23, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Mississauga (Canada)

Citations

IDCFRDescription
265021 CFR 820.30(f)Design verification - Lack of or inadequate procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures