1060614

Monterey Medical Solutions, Inc. — FEI 3004967992

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 31, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Salinas, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
237121 CFR 820.30(a)Design control - no procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures