FDA continues to step up its enforcement of CGMP regulations. In 2016, the Office of Dietary Supplement Programs was formed, elevating the program from its previous status as a division.
The grace period for even small dietary supplement companies, if there ever was one after full DSHEA implementation, is over. Failing to comply could mean facing financial penalties, FDA action, or permanent injunction against producing or selling your product.
If your company is a distributor of dietary supplements, you have a much lighter regulatory burden than a manufacturer, it’s true, but at least half the subparts of 21 CFR Part 111 still apply to you.
Polaris can help your company identify what is needed to be in compliance with FDA requirements, make recommendations on how to become compliant, assist you in implementing your plan, and prepare you for an FDA inspection.
Polaris' services include:
We conduct compliance audits
and save time to market for
our customers worldwide.
How can we help you?
Polaris Compliance Consultants, Inc.
1151 Executive Circle Suite 202
Cary, NC 27511-4589