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 3014162263.
Observations3
Issue DateJuly 21, 2023
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
BALT USA, LLC
Location
Irvine, California, United States
FEI Number
3014162263
Product Type
Devices
Issue Date
July 21, 2023
Country
United States
Inspection History, 2012 to 2025
NAI4
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
Talk to a Specialist