Preventive Controls for the biological hazards in raw cherries
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????????????
Maybe storage temperatures?
Maybe this example be useful for you.
Attached Files
Maybe storage temperatures?
The finished product is shipped directly into a freezer at a temperature of -15 degrees.
Maybe this example be useful for you.
This is basically what we do, that is why we are a little confused on this.
Here is what we have for a Hazard Analysis and Supply Chain Controls for Frozen Pitted Cherries. Maybe this will help. We had our FDA Preventive Controls audit in February and they were okay with this then.
Attached Files
What are the other potential sources of biological contamination?
Unwashed hands.
Dirty equipment.
Contaminated storage areas.
Pests carrying bacteria.
Unclean shoes or clothing.
Etc.
Do you have prerequisitie programs to cover these?
Here is what we have for a Hazard Analysis and Supply Chain Controls for Frozen Pitted Cherries. Maybe this will help. We had our FDA Preventive Controls audit in February and they were okay with this then.
Are you receiving the cherries already IQF?
What are the other potential sources of biological contamination?
Unwashed hands.
Dirty equipment.
Contaminated storage areas.
Pests carrying bacteria.
Unclean shoes or clothing.
Etc.
Do you have prerequisitie programs to cover these?
Yes we do, this is where the confusion is coming from
Are you receiving the cherries already IQF?
Yes we are.
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
The storage temperature is also a process control.
Here is what we have for a Hazard Analysis and Supply Chain Controls for Frozen Pitted Cherries. Maybe this will help. We had our FDA Preventive Controls audit in February and they were okay with this then.
Question, on your HA, how do you know what is appropriate for your suppliers preventive control? And what is your PC if you don't mind me asking?