Whether you are a large or small dietary supplement company, you need to be prepared for an FDA inspection. Since FDA began conducting inspections of supplement manufacturers, packagers, labelers, and distributors, 1 in 4 companies inspected received a Warning Letter. And FDA continues to step up its enforcement of CGMP regulations.
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.
The grace period, if there ever was one, seems to be over. If you don’t comply with CGMP regulations, you could face financial penalties, FDA action, or, as we’ve seen recently, permanent injunction against producing or selling dietary supplements.
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