1. Pink Sheet
  2. >>Compliance

The Quality Lowdown: Cleaning Issues At Mylan, Blank Release Forms At API Plant In China, And More

 
• By Bowman Cox

Mylan can look forward to mopping up some major cleaning validation issues a large team from FDA found during an extensive inspection of the firm’s West Virginia plant. Meanwhile, an API firm in China found it should not have left blank product release forms lying around pre-stamped “Permitted to Leave Factory.”

The referee gave a red card for the player in stadium

When an eight-person team inspects a pharmaceutical manufacturing plant, it will be likely to observe all kinds of problems, and that certainly was the case with a massive Form 483 report that surfaced on FDA’s web site last week after a major inspection of Mylan’s plant in West Virginia.

Meanwhile, an active pharmaceutical manufacturing plant in China was found to have data integrity issues deserving of a warning letter,...

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 Compliance

US FDA ANDA Priority Pilot ‘Practically Unusable’ Without Tweaks, AAM CEO Says

 
• By Sarah Karlin-Smith

Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.

Oz: CMS Developing Plans To Incentivize Domestic Manufacturing

 
• By Sarah Karlin-Smith

The Trump Administration’s efforts to encourage more US-based pharmaceutical manufacturing have largely centered on FDA plans and Trump’s threats of tariffs and Most Favored Nation pricing, but Oz hinted Medicare and Medicaid soon may soon announce new incentives.

New GMP Reliance Approach In Argentina Could Save Time For Companies

 
• By Francesca Bruce

New rules in Argentina mean that good manufacturing practices certificates for foreign drug manufacturing plants issued by certain regulatory authorities could lead to quicker GMP certification evaluations.

Pink Sheet Podcast: US FDA Cuts Biosimilar Requirements, Clarifies Inspection Reform

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss FDA announcements that clinical efficacy studies would no longer be required for biosimilar development, as well as the additional information from the agency on the intent of its “Simple Reform” of the inspection staff.

More from Pink Sheet

NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.

England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

The 27-year agency veteran has not been formally approached about filling the vacancy created by George Tidmarsh’s resignation, but also is not interested in the position, the Pink Sheet has learned.