Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3014298539.
Observations3
Issue DateNovember 22, 2024
StatusNo Warning Letter
Establishment TypeTissue Processor
Related Inspections10
Establishment Details
Firm
Berkeley Advanced Biomaterials, LLC
Location
Berkeley, California, United States
FEI Number
3014298539
Establishment Type
Tissue Processor
Product Type
Biologics
Issue Date
November 22, 2024
Country
United States
Inspection History, 2009 to 2024
NAI8
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.