Dinged for not having Heat Treated pallets
During our last NSF audit, prior to myself working at my company, we got a finding for not having heat treated pallets. For the life of me I cannot find a single reference in 21 CFR 111 that states you must have heat treated pallets nor does any of our internal documentation state that we only use heat treated pallets. Am I missing something?
I should say that my facility does not manufacture anything. We are a distribution center for finished goods only. We have no open items or any raw materials just finished goods. Regardless if we did manufacture at our facility I still cannot find a requirement.
Was the NSF audit done for a customer that requires HT Pallets or is NSF requiring HT Pallets on their audits?
We do have companies that use these, however it is not the norm nor have I ever seen it gigged.
NSF is specifically saying it is mandatory, our manufacturing facility is certified to NSF, we are trying to follow suit but am thinking against it now that NSF is dinging us for items that are not requirements of 21 CFR 111. I understand that the heat treat is a good idea but it is not a FDA requirement.
Question 36 on the NSF checklist,
Question # 36
There are adequate precautions against contamination by microorganisms, chemicals, filth, or other extraneous materials.
a. Warehouse facilities shall be devoid of dust and debris and free from pest indications.
b. Hazardous chemicals shall not be stored near dietary supplements.
c. There shall be a SOP for pallet control within the GMP facility to protect against contamination (wood fragments, etc.).
i. SOP for pallet control must describe were wooden pallets and non-wooden pallets are permitted in GMP area.
ii. Wooden pallets must not be used where there are exposed products (i.e. within sampling booth/room, etc.)
iii. In GMP areas where they are permitted, wooden-pallets must be heat-treated (i.e., marked with HT).
iv. Non HT-wooden pallets are sometimes chemically-treated with TBA (i.e., Tribromoanisole) or other chemicals.
Hi K Meyers. When you say "NSF checklist", what audit scheme is this referring to? Is this for a specific customer or one of NSF's product approval programs? I am not aware of NSF having their own audit scheme for distribution, but they likley provide the auditing service for the scheme you have this checklist for. Can you attach the checklist?
Specifically it is their NSF GMP Facility Registration Audit. This is for 21CFR Part 111 of which NSF will certify us too. This is not for a specific customer. This is the actual checklist that you are audited to.