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Increase In Subpar Pharmaceutical Repacking Draws US FDA Attention

 
• By Bowman Cox

Foreign tablets, active pharmaceutical ingredient residues and failed line clearance plagued operations at repackers that received FDA warning letters in FY 2023.

A foreign tablet
foreign tablets are getting firms in hot water with the fda • Source: Shutterstock

A concerning trend with good manufacturing practice deficiencies among pharmaceutical repackaging firms led a US Food and Drug Administration compliance official to underscore the concerns in his remarks at the recent Parenteral Drug Association/FDA meeting in Washington.

Key Takeaways

  • Repacker warning letters increased in FY 2023.

  • Serious patient risks, history of problems drove enforcement.

    • ...

While the agency often sends one or two warning letters to repackers in any given year, in fiscal year 2023, there were three, which prompted Francis Godwin, director of the...

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