India Facility Receives Warning Letter for Quality Violations

FDA sent a warning letter, dated March 6, 2019, to Jubilant Life Sciences after an inspection of the company’s Jubilant Generics Limited at Roorkee facility found current good manufacturing practice (CGMP) violations. The inspection, which occurred from July 30, 2018 to August 8, 2018, found that the company was not sufficiently investigating batch failures or testing in-process materials. According to FDA, similar violations were found by the company in 2016.

Specifically, the agency stated in the warning letter that the company did not “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.” FDA requested the company provide an assessment of its system for investigations of deviations, atypical events, complaints, out-of-specification results, and failures; a summary of all atypical or failing dissolution test results; a retrospective review of all complaints and associated investigations of batches within expiry; and a retrospective review of all investigations of batch rejects.

The agency also cited the company for failure to establish process controls, stating that the company did not provide FDA with a systemic review of its change management program.

“In response to this letter, conduct a comprehensive, independent evaluation of your change management system. This review should include, but not be limited to, an examination of your procedures to ensure changes are sufficiently justified, reviewed, and approved by your quality unit. The change management program should also include specific provisions for determining change effectiveness. In addition, provide the final investigation, PR 4894, regarding assay failure in batch (b)(4),” FDA stated.

Source: FDA