The SupplyChainBrain Podcast

The Challenge of Compliance: Keeping up With the FDA

8 snips
Aug 22, 2025
David Lennars, President of Registrar Corp, delves into the intricate world of FDA compliance and its implications for supply chains. He discusses recent regulatory changes affecting drug shipment logistics and the extended deadlines posed by the Food Safety Modernization Act. The conversation highlights the challenges of FDA inspections, especially for foreign manufacturers, and the impact of staff cuts on the agency’s effectiveness. Lennars also explores the interplay between tariffs and FDA regulations in the food industry, shedding light on how these factors complicate sourcing strategies.
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ADVICE

Annual FDA Registration Renewal

  • Renew FDA product and facility registrations starting October 1 each year to maintain validity.
  • Update product listings for drugs and devices during the fourth-quarter renewal window.
INSIGHT

Traceability Rule Delay Offers Breathing Room

  • The FDA delayed the FSMA 204 traceability rule, giving industry more time to comply.
  • The delay acknowledges the rule's complexity and high implementation cost for many firms.
ADVICE

Plan For Pushback And Implementation Costs

  • Expect industry pushback to influence FDA timing and seek extensions when rules are complex.
  • Plan for costly software and implementation if you must comply with traceability requirements.
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