Ranbaxys Toansa plant products banned by USFDA due to data integrity issues
Ranbaxy Laboratories had entered into a $500-million settlement in May last year after allegations of fake test results and selling of adulterated products. Now, the USFDA has banned products from Toansa plant of Ranbaxy Laboratories which has affected Ranbaxy with regards to selling products in the US market. Data integrity violations have been cited by the US regulator leading to import ban on the product manufactured at Toansa plant.
Toansa plant being the only facility of the company’s India unit that had permission for making drug ingredients to enter US market has been very important for Ranbaxy. So far there have been many allegations and import alert from USFDA for not meeting good manufacturing practices (GMP) standards and other quality issues.
According to the FDA charges in the Form 483 for the Toansa plant, the company has failed to get positive test results and there are also instances of critical records being rewritten, overwritten or back dated. Also, there were sticky notes attached to quality control data packages.
The US drug regulator is taking these actions to prevent substandard drugs from entering into the US market. The company is actively involved in taking actions aimed at complying with GMP standards. It is undertaking internal investigations and is taking appropriate management.