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

<p style="margin: 0in 0in 8pt;">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, <a href="http://www.kkblaw.com/" target="_blank">Kleinfeld, Kaplan and Becker LLP</a>, and Sandy Almendarez, editor in chief, <b>Natural Products INSIDER</b>, discuss how brands can best navigate GMP inspections, including knowing which questions supplement manufactures are required to answer, and which ones they shouldn&rsquo;t address. In addition, they discuss&nbsp;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.</p>

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.

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