1. Pink Sheet
  2. >>Compliance
  3. >>Manufacturing

FDA Warning Letter Blasts Mylan’s Continued Lax Impurity Controls for APIs

Company Needs To Beef Up Equipment Cleaning And Monitoring Of Recovered Solvents For Impurities

 
• By Joanne S. Eglovitch

Concerned about another possible nitrosamine scare, US FDA warning letter to Mylan focuses on firm’s failure to control contamination risks of its APIs and its inadequate testing of reused solvents.

Vintage inscription made by old typewriter, warning
FDA Tells Mylan To Learn From Earlier Mistakes • Source: Shutterstock

A warning letter the US Food and Drug Administration sent on 20 August to Mylan Pharmaceuticals Inc. targets the firm’s lax cleaning procedures for equipment holding and manufacturing active pharmaceutical ingredients and a failure to test reused solvents used to make APIs at the Mylan Unit 7 facility in Pashamylaram, India.

The warning letter underscores the FDA’s concern with the possibility of another nitrosamine scare that emerged from the 2018 discovery of carcinogenic nitrosamines in APIs for certain blood pressure medicines worldwide

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

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
• By Jessica Merrill

At the Bank of America health care conference, pharma leaders speculated on the impact of Trump’s most favored nation pricing executive order on US and European markets.

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

More from Compliance

US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops

 
• By Anju Ghangurde

As the US FDA expands unannounced foreign inspections building on pilots in India and China, experts expect higher scrutiny of overseas sites and perhaps even an industry shakeout in the longer term, though staffing and enforcement challenges could slow things down.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.