FDA Compliance Group LLC

Your solution to FDA compliance needs
FDA Compliance Group is located in Denver, Colorado

Dietary Supplements ~ FDA Consulting Services

At FDA Compliance Group, our FDA consultants have all worked for the FDA – as investigators and/or compliance officers – or have extensive experience in the dietary supplements industry.

With the services listed below, we can help you obtain and maintain full FDA compliance with all regulations and requirements.

FDA cGMP Compliance Audits and Gap Analyses
We can evaluate the compliance level of your manufacturing, quality, and laboratory systems (with 21 CFR Part 111 and other applicable FDA regulations) and provide counsel for how to become fully compliant. We can also perform audits on outside facilities, including contract manufacturer cGMP inspections, vendor qualifications, and contract laboratories.

FDA Inspections and FDA Warning Letters
We can step you through the intricate process of correctly responding to an FDA Form 483 (Inspectional Observations) or FDA Warning Letter for dietary supplements. In most cases, a well-crafted 483 response or Warning Letter response can help avoid additional regulatory action by the FDA. We can also assist with FDA inspections, offering counsel on pre-audit preparedness, accompanying you onsite for the inspection, and more.

FDA Adverse Events
We can provide guidance for your record keeping and SAE (Serious Adverse Event) reporting that fully complies with FDA requirements and regulations for dietary supplements. In the event of an FDA product recall or other FDA regulatory action, we can provide advice on the steps that will need to be taken.

FDA Specifications, Procedures, and Documents
We can write and help you implement cGMP compliant procedures, protocols, and work instructions. We can assist in developing master manufacturing and batch production records that meet all of the applicable FDA regulations for dietary supplements. We can help you develop and write specifications for raw materials, in-process, and finished products that include suitable criteria for identity, purity, strength, and composition. We can also advise on finished product and identity testing strategies and protocols for dietary supplements.

FDA Qualification
We can qualify your processes and procedures for dietary supplements, such as finished product testing, weighing and blending operations, facility and equipment cleaning methods – and ensure that they are properly documented. We can also qualify your computer applications for 21 CFR Part 11 compliance, including ERP software, data storage and collection systems, laboratory information systems, and more.

FDA Staff Training
We can customize training for your specific FDA needs, such as: cGMP compliance, FDA inspection preparedness, and quality systems management.

FDA Regulatory Affairs Assistance
We can review websites and dietary supplement labeling to ensure that it is in compliance with FDA regulations for marketing and promotion. We can also perform NDI notification submissions and GRAS determinations. In addition, we can provide nonclinical and product safety assessment guidance prior to potential production commercialization or acquisition.

For more information on FDA consulting services for dietary supplements or to schedule a consultation, please contact us.