Canton Laboratories receives US FDA warning letter

The US FDA has issued a warning letter to Vadodara-based Canton Laboratories for violations of current Good Manufacturing Practices (cGMP). US FDA during its inspection of Canton’s pharmaceutical manufacturing facility located at Vadodara from April 1-9, 2013, identified significant deviations from cGMP for the manufacture of active pharmaceutical ingredients (APIs). Following this, the regulator issued a warning letter at the end of February 2014 to Canton Laboratories.
 
US FDA has raised questions ranging from issues identified in laboratory testing, inadequate maintenance of data from tests conducted, and unsatisfactory cleanliness of equipment. The regulator has told the company to provide, within 15 days of receipt of the warning letter, specific steps taken to correct and prevent the recurrence of deviations with supporting documentation.
 
US FDA letter warned, “Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer.  In addition, your failure to correct these violations may result in FDA refusing admission of articles manufactured at Canton Laboratories Private Ltd, Vadodara, into the US.”