988074

T2 Biosystems, Inc. — FEI 3010097867

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 16, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Lexington, MA (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures