Sponsored By

Healthy INSIDER Podcast 35: FDA GMP Inspections Focus on Complex, Botanical Products

As FDA becomes more experienced at inspections for good manufacturing practices (GMPs) for dietary supplements, its processes have gotten more sophisticated. The agency knows which questions to ask and which products to target to reveal lapses in manufacturing processes. In this podcast, Tony Young, partner, Kleinfeld, Kaplan and Becker LLP, and Sandy Almendarez, editor in chief, Natural Products INSIDER, discuss how brands can best navigate GMP inspections, including knowing which questions supplement manufactures are required to answer, and which ones they shouldn’t address. In addition, they discuss types of products inspectors are most likely to follow through manufacturing and request paperwork for and how to address form 483 reports and what to do if a company can correct observations during the inspection.

As FDA becomes more experienced at inspections for good manufacturing practices (GMPs) for dietary supplements, its processes have gotten more sophisticated. The agency knows which questions to ask and which products to target to reveal lapses in manufacturing processes.

In this podcast, Tony Young, partner, Kleinfeld, Kaplan and Becker LLP, and Sandy Almendarez, editor in chief, Natural Products INSIDER, discuss how brands can best navigate GMP inspections, including:

  • Knowing which questions supplement manufactures are required to answer, and which ones they shouldn’t address

  • The types of products inspectors are most likely to follow through manufacturing and request paperwork for

  • How to address form 483 reports and what to do if a company can correct observations during the inspection

This podcast follows a webinar conducted by the American Herbal Product Association (AHPA), where Young goes more into depth about GMP inspections and other speakers cover best practices to follow during an inspection. Check out the webinar, “FDA Inspections, Warning Letters and Emerging cGMP Compliance Issues” on the AHPA website.

Links and resources:

About the Author(s)

Sandy Almendarez

VP of Content, Informa

Summary

• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

Contact:

Subscribe and receive the latest insights on the health and nutrition industry.
Join 37,000+ members. Yes, it's completely free.

You May Also Like