FDA EIR - Sun Pharmaceutical Industries, Inc. - March 09, 2018

Sun Pharmaceutical Industries, Inc. in Cranbury, NJ, was subject to an FDA cGMP inspection from February 13 to March 9, 2018, to assess compliance with Current Good Manufacturing Practices for solid oral dosage drug products. The inspection revealed multiple deficiencies documented in an FDA-483. Main violations included inadequate pre-packaging line clearance, insufficient review of laboratory data, and poor facility maintenance, evidenced by chipped paint, ceiling damage, and worn equipment like scrapers and blenders. The firm also failed to determine why batch record limits were unachievable and did not establish robust measures to prevent the receipt of incorrect components from vendors used in packaging operations. Additional concerns involved the lack of periodic challenge for packaging line equipment to detect erroneous tablets and the absence of corrective actions for identified medication guide and bottle size errors from suppliers. Issues with water system monitoring data manipulation and daily check procedures, along with several labeling errors in multiple drug products (Spironolactone, Chlorthalidone, Doxycycline Hyclate) that were missed during acquisition, further compounded the findings. Company management acknowledged the observations and pledged to submit a written response within 15 business days, indicating a need for comprehensive corrective and preventive actions to ensure regulatory adherence.