We had a FDA inspection this summer, and we were told that we have no preventive control for the biological hazards associated with raw cherries. And, if the control is applied at another manufacturer we must get a letter stating that, 117.136(a)(2)(i).......we chlorinate our water, so what other control would we be looking for????????????
Hi jalex,
So what were the specific biological hazards in yr harpc plan which FDA apparently did require to be prevented ?
(might be convenient to post yr harpc plan)
@ Pie Guy - Thks yr input. Nice layout although I have a few reservations about content, eg -
In view of FDA's published views on foreign material hazards, IMO the cherry pits in yr plan should not require a PC.
The justifications given for no required PCs for biological/pesticide hazards seem like fudges to me unless some futher corroborative data was specifically/additionally provided, eg official micro. appraisals of the raw cherry supply industry and/or local testing of incoming material lots.
Nonetheless, I am not in USA so perhaps these are implicitly/officially approved fudges