KKB Partner Tony Young Participates in Podcast on Dietary Supplement GMP Inspections

As FDA has gained more experience with inspections for good manufacturing practices (GMPs) for dietary supplements, its processes have become more sophisticated.  The agency knows which questions to ask and which products to target to reveal lapses in manufacturing processes.  In a recently released podcast, KKB partner Tony Young and Sandy Almendarez, editor in chief, Natural Products INSIDER, discussed how industry members 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; and
  • 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), during which Mr. Young addressed in greater depth GMP inspections.  Check out the webinar, “FDA Inspections, Warning Letters and Emerging cGMP Compliance Issues,” on the AHPA website.