847750

SDI Diagnostics, Inc. — FEI 1220253

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 10, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
South Easton, MA (United States)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
405721 CFR 820.20(a)Management ensuring quality policy is understood