The US health regulator has issued a warning letter to Jubilant Life Sciences red flagging significant repeat violations of good manufacturing norms at the company's Roorkee facility. In a letter to the company's CEO Pramod Yadav, the US Food and Drug Administration (USFDA) said, "Your investigations into deviations and consumer complaints were inadequate."
The letter said that the USFDA has strongly recommended engagement of a consultant to assist the company in meeting CGMP requirements as the firm failed to correct repeat violations. Pointing out that the lapses could impact approval for new products from the facility, the letter said, "Until you correct all violations completely and we confirm your compliance with CGMP, the FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer."
According to the letter, the company did not adequately justify root causes, expand investigations to all potentially affected batches, implement corrective action and preventive actions (CAPA) in a timely manner, or evaluate CAPA effectiveness, it added. While stating that the firm had opened investigation on December 14, 2017, after discovering a particle size issue for crospovidone excipient associated with the manufacture of multiple drug products, and identified the root cause as an incorrect crospovidone internal label on one drum in a shipment, it could not confirm the assumption that only one drum in that shipment was mislabeled.
"Although you expanded your investigation and identified 12 batches of valsartan tablets for the US market that used crospovidone from the same shipment as the mislabeled drum, only two batches were recalled on May 17, 2018. Your firm failed to recall the remaining ten batches until August 14, 2018," the letter said. The company also failed to perform dissolution testing on numerous complaints for damage to functional coating on pantoprazole delayed release tablets in a batch including peeling, rippled, 'wet', discoloured, and sticking tablets, it added.
"Your investigation was insufficient in timeliness and depth to address the scope of the issue. After the investigation was closed, you found several more lots with defective coating and issued a recall," the letter said. Red flagging another issue, the regulator said: "Your firm's quality control unit failed to test and reject in-process materials that did not conform to appropriate testing during the production process."
Stating that the response of the company was inadequate on the issues, and that these were repeat violations, USFDA said in a previous inspection, dated April 4 to 8, 2016, it had cited similar CGMP violations. "You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," it added.
Stating that the company needed a CGMP consultant, the letter said that as the company failed to correct repeat violations, USFDA strongly recommends engaging a consultant qualified to assist the firm in meeting CGMP requirements. Emphasising that this could impact approval for the new products from the facility, the letter said: "Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer."
Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Jubilant Generics Limited at Roorkee, it added. Giving the company 15 days to respond, USFDA Consumer Safety Officer Marisa Heayn said in the letter: "After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done since our inspection to correct your violations and to prevent their recurrence."
Earlier on March 8, Jubilant Life Sciences in a regulatory filing had said it had received a warning letter for its Roorkee facility and "is committed to implementing the necessary corrective actions required to address USFDA concerns and is in the process of providing a thorough and comprehensive response to the USFDA within 15 working days." PTI AKT MR