FDA Frequency Requirement for External AOAC lab test for Histamine

Hi all;

 

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?

 

thanks

Although the FDA guide “recommends” quarterly verification, keep in mind that it is very difficult to convince FDA that something other than their recommendation is acceptable. So I would strongly suggest you revert to quarterly verification with external lab. If your last external verification test was more than 3 months ago, I would suggest submitting a sample ASAP.

Thank you, Fishlady;

 

I will send samples asap.

 

cheers