Ranbaxy Inc. – FDA EIR, Jun 20, 2017

An FDA inspection of Sun Pharmaceutical Inc.'s Princeton, NJ headquarters and generic drug manufacturing facility occurred from June 14 to June 20, 2017. The inspection, requested by CDER and guided by CPGM 7353.001, focused on the company's Postmarketing Adverse Drug Experience (PADE) reporting processes. While no formal FDA-483, Inspectional Observations, was issued, key findings were discussed verbally with management. Major issues included non-operational dry fire suppressants in the server room, which houses critical safety databases for North American operations, and an incorrect determination of "Day 0" for certain safety reports, failing to align with the initial awareness date by any company employee or location. Additionally, the general training provided to employees regarding safety information reporting presented an inadequate definition of an Adverse Drug Experience (ADE), omitting crucial categories such as overdose, drug abuse, drug withdrawal, and failure of expected pharmacological action. Management acknowledged these findings and committed to implementing corrective actions, including ensuring proper fire suppressant installation, training personnel on accurate "Day 0" determination, and updating the comprehensive definition of an ADE in employee training materials.