2 replies to this topic

[Apagano28]

Hello, 

 

I am "battling a manufacturer"  to receive a Certificate of Analysis, Certificate of Conformance, and a copy of the executed production record to review for dietary supplements prior to release from my warehouse.  The manufacturer manufacturers and final packages the product for context.   They are pushing back and requesting what FDA requirement states that they need to supply those items to a customer. I distribute from my warehouse, also for context.  I have never had an issue with this before and typically as a customer, I request an executed batch record annually ( they are pushing back on this as well). That being said, I am struggling to "hit them with the GMP book" as the regulations (part 111) don't state these requirements specifically.  Any help would be greatly appreciated. 

[jdpaul]

It sounds like the supplier (also the manufacturer) is the one already doing the verification of the dietary ingredients, no? I would read through section 111.75 (111.75 What must you do to determine whether specifications are met?) as it seems to imply some of the records they should already have on hand. Whether they are required to give those to a distribution center is up to what the standard says and I am not finding anything relevant under 21 CFR Subpart B

Edited by jdpaul, 02 February 2022 - 09:33 PM.

[Angus86]

Do you have any stake in the products other than distribution? If you are the brand owner of the supplement, you have ground to stand on for requesting the batch records for ongoing quality and safety monitoring for the protection of your brand. 

 

If you are the warehouse owner/operator, the COA and SDS should definitely be shared with your facility. However, the batch records are likely proprietary and confidential and should not be shared with anyone other than the "owners" of the formula.