To update our crisis management/recall procedures, I've been reading the FDA recall guidances and other information about the RFR and I still have some doubts about regulatory requirements. I've also been searching on this forum and I haven't found anything that specifically answers my questions.
If a customer (nor a retailer, neither a consumer) informs me that they have found a microbiological issue in an ingredient I have sold them, but they are going to "solve" the problem (heating or irradiating. not as a part of their process), should they report that to the RFR? should I? It's not yet in the supermarket shelves, it's in their warehouse, so does it fit in the definition of reportable food?
"...an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals". Let's imagine that the problem is a low recount (<100 cfu/g generic) of E.coli in an ingredient that won't support its growth.
Apart from that, the FDA guidances for the RFR (https://www.fda.gov/...stablished-food) has the following Q&A:
I.1 [Amended May 2010] If a responsible party (Party A) notifies the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food (Party B), as required by FDA, should Party B submit a report to FDA and provide a notification to Party B’s own immediate previous source(s) and/or immediate subsequent recipient(s)?
Yes, if Party B meets the definition of a responsible party, Party B should submit a report to FDA as soon as practicable, and within 24 hours after receiving the notification regarding the reportable food. FDA may require Party B to submit a report to FDA as soon as practicable, but in no case later than a time specified by FDA, and/or to provide a notification to Party B’s own immediate previous source(s) and/or immediate subsequent recipient(s) of the reportable food. See the response to Question I.5 for more information.
This confuses me so hard. Thoughts anyone?
Edited by Drumstick, 13 May 2019 - 08:19 PM.