During an FDA inspection at a Vietnamese seafood processor, investigators observed noncompliances with the processor’s HACCP program.
Among the serious concerns were that the hazard analysis did not identify scombrotoxin (histamine) formation as a potential hazard and that critical limits for refrigerated temperatures required to control C. botulinum growth and histamine formation were not adequate. Additionally, both the monitoring procedures for histamine management and corrective action procedures for histamine management were considered to be inadequate.
Regardless of where products are produced, if they are to be imported into the U.S., all applicable regulations must be followed.
