FDA Dietary Supplements Compliance

Dietary supplements present a great opportunity for marketing and sale on the U.S. market. FDA’s dietary supplements Compliance regulatory system for manufacturing, labeling, manufacturing facility registration, and product distribution is well defined and includes some of the most stringent requirements.

However, do not let the complexities of FDA dietary supplements regulations deter you from entering the dietary supplements market. mdi Consultants is well prepared to assist you with all phases of dietary supplements compliance.

• Gap analysis of the company’s operations for compliance with FDA cGMP requirements in 21 CFR Parts 111 and 117.
• Inspection of manufacturing facilities, equipment, processes, and employee work practices.
• Review the company Standard Operating Procedure against the FDA requirements.
• Review of Master Manufacturing Records, Batch Production Records and other supporting documentation.
• Review of supplier Certificates of Analysis and recommendations on incoming ingredients testing.
• Review of the finished product testing in support of the product label claims.
• Review of the test method protocols for ingredient and finished product testing.
• Review the product structure function claims against the available supporting evidence and in the context of FDA regulations.
• Review of the product labeling against FDA regulations for dietary supplements labeling.
• FDA registration of dietary supplement manufacturing establishment.
• Assistance with written responses to FDA-483’s, warning letters and consent decree.
• Assistance with quality system remediation measures in response to FDA inspection.