Hi, we are regulated in the United States under 21 CFR Parts 117 and 111 and manufacture dietary supplements.
For those of you under Part 117, for §117.410(e), if you find that the supplier is not controlling a hazard that the receiving facility has identified as requiring a supply-chain-applied control, what would you do?
Would you quarantine product, drop the supplier, do additional testing, or a combination of these?
Thank you,
Matthew