Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3008776041.
Observations3
Issue DateAugust 14, 2012
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Sekisui Diagnostics, LLC
Location
Burlington, Massachusetts, United States
FEI Number
3008776041
Product Type
Devices
Issue Date
August 14, 2012
Country
United States
Inspection History, 2012 to 2019
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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