Hello all,
Occasionally, we have a complaint/return investigation that we need to conduct, and when we try to contact the customer, problems frequently arise when people have purchased through a certain e-commerce distributor: This distributor does not allow us to contact the consumer directly for complaint/return investigations, even just to get the lot number and clarify the information they are telling us. My coworker tells me, "(distributor name) does not want communication with customers outside of the (distributor name) platform." "The fact that I am even communicating outside of the (distributor name) platform...could result in termination of our (distributor name) account a forfeiture of a (dollar amount) business." This includes situations where there is an adverse event, and as you might know, if it is a serious adverse event, this necessitates a mandatory report to the FDA.
Therein lies our dilemma: How do we get the required information to comply with our procedures (for complaints, returns, and adverse events) and comply with regulations while navigating the rules that our e-commerce distributor has for our account and not lose their business? Does anyone have experience with this, and what are you doing in this area?
We have SQF and NSF GMP certifications and we are following 21 CFR Part 111 for dietary supplements in the United States.
Thank you,
Matthew