1. Pink Sheet
  2. >>Compliance

FDA Warning Letter Hits Akorn’s Subpar Root Cause Investigations

 
• By Joanne S. Eglovitch

Akorn has been hit with its second warning letter this year, this time for similar issues at a different site, where the US FDA found the firm failed to adequately address problems with impurities and bottle defects. The Akorn letter may also be symptomatic of a larger problem being seen by the agency in the growing number of faulty root cause investigations.  

Warning Rubber Stamp

The US Food and Drug Administration has targeted Akorn Inc. with faulty root cause investigations into problems with impurities and bottle defects, poor aseptic practices and inadequate control over computer equipment in a 13 June warning letter. The agency also blasted the firm for not fixing past good manufacturing practice problems.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Manufacturing

More from Compliance