In August 2007, the U.S. Food and Drug Administration (FDA) issued the final ruling: 21 CFR Part 111, "Current God Manufacturing Practices for activities related to Manufacturing, Packaging, Labeling or Holding Dietary Supplements".  This regulation establishes minimum controls necessary to ensure Quality, Safety, and Uniformity of Dietary Supplements / Nutraceuticals.  This rule applies to all companies that manufacture, package, label, or hold such products for sale in the United States.  If you manufacture or supply Nutraceuticals, you should take action to be in compliance with 21 CFR Part 111, and LexaMed can help!

For manufacturers, packagers, warehouses and shippers of dietary supplements having 500 or more employees, compliance to 21 CFR Part 111 is now mandatory. 

LexaMed  has the unique experience and curriculum to show your company how to meet the requirements of 21 CFR Part 111.  We provide "Hands On" solutions to quickly and efficiently safeguard your company against the negative impact of non-compliant practices.  LexaMed  has been a leader in the field of Nutritional Supplement Quality in the areas of:

• Auditing against Part 111, Gap Assessment, Quality System Review, Facility Evaluation.
• Identifying critical areas needing development, improvement or renovation.
• Planning compliance goals and projects.
• Implementing proven solutions, programs, training and execution
• Assessing the effectiveness and sustainability of your company's compliance program.

Let LexaMed , not the FDA, help you find your potential compliance issues! Contact us today to discuss the impact of these regulations on your business!