Storage facility without third party audit
Full details:
Facility info: We specialized in food processing chemicals and cleaning chemicals so secondary additives all low risk.
Due to insurance purposes we are being required to relocated all flammables and oxidizers out of our facility and many of these items are part of our scope and food chemical codex grade chemicals.
The 3rd party warehouse facility does not have a third party audit and is also not registered with the FDA. They do have a pest control company and a cleaning program, they have a security company and system and segregation capabilities.
I know I need to consider them as a Contract manufacturer but without the FDA registration would they even be able to do this for us?
Any advice is appreciated including the contract warehouse part. I am starting from scratch as we do not do any contract manufacturing at this time. Including example SOP’s and forms 😊 Thank you!
As your product is low risk, the third party warehouser doesn't have to be SQF certified. But you must ensure they are abiding by SQF code (per SQF 2.3.3.2).
But the fact they're not registered is a huge no-go. Bioterrorism Act of 2002 applies to every company "...engaged in manufacturing, processing, packing, or holding food for consumption in the United States..." It also violates SQF code to engage with a third party distributor who isn't abiding by all regulations (per SQF 2.3.3.3).
As your product is low risk, the third party warehouser doesn't have to be SQF certified. But you must ensure they are abiding by SQF code (per SQF 2.3.3.2).
But the fact they're not registered is a huge no-go. Bioterrorism Act of 2002 applies to every company "...engaged in manufacturing, processing, packing, or holding food for consumption in the United States..." It also violates SQF code to engage with a third party distributor who isn't abiding by all regulations (per SQF 2.3.3.3).
I agree with Jfrey's comments.
Am I missing something or did the original poster say they produce food processing chemicals and cleaning chemicals? If that is truly the case how is the 3rd party site in violation for not being registered as it is not a food facility? The site would just be storing flammable chemicals for them.
@Scotty_SQF, op stated the food processing chemicals are "secondary additives", so I'm taking that to mean a chemical ingredient for a finished product.
If I'm wrong on that and it's all just food grade cleaners/sanitizers, I think that would make a non-registered facility okay. I'd still want to audit their facility to ensure it has pest control and some type of defense program in place to meet SQF's requirement on 3PL's, but it should be clear from the registration standpoint described in CFR's.