Basics of GMP’s Cited

Functional mushroom products are undergoing a renaissance, and FDA is paying close attention to how these products are tested and manufactured. This is likely because of the mass recall and potential fatalities associated with the Diamond Shruumz products. Learn more about this cringy and dangerous recall here.

Today’s Warning Letter Wednesday highlights GMP violations related to functional mushroom incoming product testing, QC release, product returns, incomplete 483 responses, and sample retention. These are important reminders of the basic GMP requirements, and we can learn from this company’s oversights.

🔹The company appears to be a copacker that received bulk mushroom gummies for packaging and labeling. They did not have even the most basic procedures in place for receiving and packaging dietary supplements. This seems like an operation that just buys bulk products then packages and labels them without quality checks. Yikes! If I had to guess, they were probably the cheapest option, which goes to show that if a price is too good to be true, it probably is. This is accurate not only for products but also for regulatory consulting as well. 

👉From warning letter. “During the inspection, you did not have any procedures in place for the dietary supplement products you receive for packaging and labeling.”

🔹Product returns are common and having a procedure of how to handle these products is essential. This warning letter indicates that returned products were possibly re-sold without proper review, which is terrifying. This is how counterfeit, or dangerous products work their way into the supply chain.

👉From warning letter. “You do not have any procedures in place for the handling of returned dietary supplements, to include the identification and quarantine of the products until quality control personnel conduct a material review and make a disposition decision.”

🔹Product retentions are important, as they allow us to retest products when there are customer complaints. FDA requires they be kept one year past expiration date or two years past the last date of distribution. In my contract manufacturing days saving three bottles per lot number was sufficient. Also, retained samples can potentially be used to substantiate expiration dating.

👉From warning letter. “ You did not retain reserve samples for the required time for use in appropriate investigations.”

The FDA gave this company ample opportunity to comply with the 483 violations but, as noted in the warning letters, the responses were incomplete which led to this warning letter. When in doubt, hire an expert for 483 responses.

Read the full letter here.

DATE ORIGINALLY POSTED: 12/11/24

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.