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Systemic Data Manipulation Uncovered at India’s Ipca Labs

  • Post author:Sam
  • Post published:March 8, 2016
  • Post category:Drug GMP Report

The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Source: Drug…

Continue ReadingSystemic Data Manipulation Uncovered at India’s Ipca Labs

FDA Continues Nationwide Inspections of Compounding Pharmacies

  • Post author:Sam
  • Post published:March 8, 2016
  • Post category:Drug GMP Report

The FDA is continuing its nationwide effort to single out compounding facilities that don’t conform to GMP regulations, and it blasted two pharmacies in Florida in recent warning letters. Source:…

Continue ReadingFDA Continues Nationwide Inspections of Compounding Pharmacies

Analysis: State Rules for Compounding Vary Widely

  • Post author:Sam
  • Post published:March 8, 2016
  • Post category:Drug GMP Report

A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Source: Drug GMP Report

Continue ReadingAnalysis: State Rules for Compounding Vary Widely
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