I'm having an FDA audit this month, and I am just wondering if there are any requirement for the frequency of Histamine testing in FDA regulation. I just cant find it. Can anyone show me?
Just a bit of intro for my company procedure,
- we do histamine testing of all lots (in-house testing) following the FDA guide 18samples
- we do quarterly histamine test with external labs in previous years and just this year, we did 6-monthly in accordance to our national change in regulation that requires only 6-monthly test.
In the Fish and Fishery Guide Pg 136 it stated quarterly tests for AOAC comparison - I know this only example, and in Pg 132 for verification, it only stated "periodically verify histamine findings.." no specified time period. Now I am bit worried, that i may not comply to the FDA if the example in Pg136 is really the requirement.
Can anyone help?