FDA Sends ‘Non-Compliance’ Letter to Sun Pharma
FDA has sent a letter to Sun Pharma telling the company that it is out of compliance with a 2012 consent decree after an inspection last year at the company’s Mohali (Punjab), India cited significant GMP violations and the agency classified the inspection as “Official Action Indicated."
“U.S. FDA has directed the company to take certain corrective actions at the Mohali facility before releasing further final product batches into the U.S.," the company said in a statement. “These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility. The company is taking required corrective steps, but there will be a temporary pause in release of batches from Mohali until U.S. FDA-mandated measures are implemented.”
The 2022 FDA inspection resulted in a six-item Form FDA-483. The form cited Sun for failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, the agency said a company investigation into alleged backdating by quality assurance and quality control personnel confirmed this was occurring, but it was not thorough enough to evaluate the scope of records being backdated.
FDA also cited the firm over its established sampling plans, test procedures and laboratory control mechanisms, which the agency said were not being documented at the time they were performed. Additionally, the agency took issue with the company’s written procedures, which it said were not drafted, reviewed and approved by the appropriate organizational units or reviewed and approved by the quality control unit.
Sun inherited the facility when it acquired Ranbaxy Laboratories in 2015. In 2013, while Mohali was still part of Ranbaxy, the agency added it to a 2012 consent decree with Ranbaxy after two 2012 inspections found significant current good manufacturing practice regulation violations.
In 2012, Ranbaxy agreed to plead guilty (see story) and pay a $500 million penalty for making and distributing adulterated drugs, the largest fine ever against a generic drug maker. The $500 million includes a criminal fine and forfeiture totaling $150 million and $350 million to settle civil claims under the False Claims Act and related state laws.
The 2012 decree (see earlier story) contains a provision permitting FDA to order that terms of the decree be extended to any company-owned or operated facility if an inspection determines that it is in violation of Federal Food, Drug, and Cosmetic Act or FDA regulations, including GMPs. Under this extension, the agency in 2013 put the Mohali facility on an import alert until the firm’s methods, facilities, and controls used to manufacture drugs at the facility are in compliance. In 2017, FDA notified Sun Pharma that it lifted the import alert imposed on the Mohali manufacturing facility, clearing the path for the company to supply approved products from the facility to the U.S. market under standard FDA regulatory requirements.