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 3015422154.
Observations6
Issue DateFebruary 26, 2025
StatusNo Warning Letter
Related Inspections2
Establishment Details
Firm
Biofusion Management and Manufacturing, LLC
Location
Austin, Texas, United States
FEI Number
3015422154
Product Type
Devices
Issue Date
February 26, 2025
Country
United States
Inspection History, 2019 to 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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