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Healthy INSIDER Podcast 13: FDA GMP Numbers Tell Story of Supplement Compliance

A Freedom of Information Act (FOIA) request found 58 percent of supplement manufacturers aren't living up to the full expectations of GMPs (good manufacturing practices) set forth by FDA nine years ago. The numbers are improving compared to past years, but, per FDA inspections, failure to set specifications is still the most common citation.

A Freedom of Information Act (FOIA) request found 58 percent of supplement manufacturers aren’t living up to the full expectations of GMPs (good manufacturing practices) set forth by FDA nine years ago. The numbers are improving compared to past years, but, per FDA inspections, failure to set specifications is still the most common citation.

In this episode, Sandy Almendarez, editor in chief, and Josh Long, legal and regulatory editor, INSIDER discuss:

  • GMP inspection data from fiscal year 2015, including the number of inspections, the number of form 483 issued, and the number of companies that were reinspected.
  • Why the nature of violations and the reinspection data are the most important aspects of these numbers.
  • If FDA is using its authority properly to ensure the supplement market is safe for consumers.

 

Links and Resources:

 

Got feedback? Email Sandy Almendarez at sandy.almendarez@informa.com or Josh Long at josh.long@informa.com, or tweet to @NatProdINSIDER using the hashtag #INSIDERpodcast.

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