US FDA Finds Poor Data Integrity At Second Intas Plant

After machines counted particles in vials, workers revised reports so out-of-specification batches could be exported to the US and the EU.

Counting particles in vials
the art of counting particles at intas • Source: Shutterstock

A 12 May 2023 inspection of an Intas Pharmaceuticals Ltd. plant in Sarkhej, a suburb of Ahmedabad, India, has uncovered another stunning display of data manipulation at the firm, according to the US Food and Drug Administration’s 15-observation, 29-page Form 483 report of inspectional observations. 

The facility is just eight kilometers up National Highway 47 from Intas’ Matoda plant, where in November FDA investigators

Generics Bulletin Podcast

Stay ahead of every shift in generics and biosimilars.

Generics Bulletin brings you the latest updates that matter for the off-patent industry.

More from Manufacturing

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C13

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C12

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

ADHD Medications and Cardiovascular Effects: New Data Revealed. (A Comprehensive Evaluation of Emerging Clinical and Epidemiological Evidence on the Cardiovascular Effects Associated with Prescribed Medications for Attention Deficit Hyperactivity Disorder) - Clone

 
• By 

A look at new research on the cardiovascular effects of ADHD medications and what it means for clinical care. This article explores the latest clinical and epidemiological research on the cardiovascular effects of medications commonly prescribed for ADHD, examining potential heart-related risks, underlying mechanisms, and their implications for patient safety, clinical decision-making, and long-term treatment strategies across diverse age groups and risk profiles.

Type:DisclosureDevelopments | Publication:GB | Section:Business | Paywall:Free — Article containing all Composer content for testing (Do not update)

 
• By 

Video provides a powerful way to help you prove your point. When you click Online Video, you can paste in the embed code for the video you want to add. You can also type a keyword to search online for the video that best fits your document.

More from Business

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success - C8

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

UK Invests £28m In NHS AI, But Industry Says Procurement And Training Will Determine Success

 
• By 

The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.

Top 10 Drugs Q1 2026: New Sheriff In Town As Mounjaro Unseats Keytruda - Clone - Clone

Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains