GMP Dietary Supplements Services

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:

• Consulting on issues in all phases of Manufacturing, QC laboratories, and Quality Assurance
• Inspection of manufacturing and warehousing facilities
• SOP writing and record keeping to comply with 21 CFR Part 111
• Training to comply with 21 CFR Part 111
• Mentoring staff in areas of Quality Assurance and 21 CFR Part 111 compliance
• Developing Vendor Certification programs, CAPA programs, and internal and external auditing 
• Performing FDA Inspection Readiness audits
• Interfacing with the FDA’s regional and headquarters offices