Essential Nutrition Law Blog : Northwest Nutraceutical Lawyers & Attorneys : Stoel Rives Law Firm : Dietary Supplements, FDA Regulation

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The dietary supplement industry has faced uncertainty over how FDA Inspectors will enforce the new Good Manufacturing Practice (GMP) regulations (21 C.F.R. 111).  GMP inspections began last year, and dietary supplement manufacturers can now look to inspection observations reports filed by FDA inspectors to prepare their companies in advance of GMP inspections.

Although the GMP regulations currently apply only to companies with more than 20 employees, the rules are set to expand to include smaller manufacturers soon.  Steve Meyers, of NaturalProductsInsider.com recently prepared a good summary of FDA inspection observation reports filed within the past year.  Here are the higlights:

• Procedures:  Inspectors carefully analyze a company’s procedures to ensure that procedures are written, complete, and cover every element of the manufacturing process. 
• Implementation of Procedures:  Inspectors focus on how effectively each aspect of the company’s written procedures are being implemented.
• Cleanliness:  Inspectors focus heavily on cleanliness of the facility, how materials are transported and stored, sanitation procedures, etc.
• Testing:  Inspectors focus how effectively the company tests each phase of the manufacturing process, from identifying the quality of the raw materials to verifying the strength of the seal on the packaging.
• Design of Facility:  Inspectors even focus on the overall design of the facility, including wither the design ensures proper sanitation, quality control procedures, etc.