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FDA Frequency Requirement for External AOAC lab test for Histamine


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#1 ennyk

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Posted 31 July 2019 - 10:00 PM

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



#2 Fishlady

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Posted 11 August 2019 - 07:05 PM

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.



#3 ennyk

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Posted 11 August 2019 - 10:28 PM

Thank you, Fishlady;

 

I will send samples asap.

 

cheers






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