726575

SDI Diagnostics, Inc. — FEI 1220253

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 29, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
South Easton, MA (United States)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
313021 CFR 820.100(a)Lack of or inadequate procedures
313921 CFR 820.140Lack of or inadequate procedures for handling
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
337521 CFR 820.198(e)Records of complaint investigation
383721 CFR 820.25(b)Training records