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 3004170064.
Observations6
Issue DateNovember 12, 2021
Status1 Related Warning Letter
Related Inspections6
Establishment Details
Firm
TEI Biosciences, Inc.
Location
Boston, Massachusetts, United States
FEI Number
3004170064
Product Type
Devices
Issue Date
November 12, 2021
Country
United States
Inspection History, 2009 to 2023
NAI2
VAI2
OAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.