FDA EIR - Dr. Reddy's Laboratories, Inc. - February 07, 2020

An FDA routine surveillance Postmarketing Adverse Drug Experience (PADE) inspection of Dr. Reddy's Laboratories, Inc. in Princeton, NJ, was conducted from January 31 to February 7, 2020. This inspection, guided by regulatory framework CP7353.001, focused on the company's pharmacovigilance processes for various drug products, including Atorvastatin, Bortezomib, and Fentanyl Citrate. Review areas included Safety Data Exchange Agreements, training, vendor contracts, written procedures, and various adverse event reports.

While no official Form FDA-483 (Inspectional Observations) was issued, the inspection identified three discussion items for management. Main issues included an instance where a periodic adverse drug experience report (PADER) for Carboprost was submitted late due to employee error. Management was also instructed to ensure that MedWatch Form FDA-3500A for their Over-the-Counter (OTC) product, Doan’s Extra Strength Capsules, was correctly marked as a 15-day report when serious cases necessitate it. Additionally, the FDA reiterated the importance of submitting all 15-day expedited adverse event reports promptly; while past delays in these reports were noted due to systemic issues (database upgrades, employee errors, and EDI connection), the company had already addressed the root causes, preventing a formal citation. Required actions involve ensuring timely report submissions, accurate form completion, and sustained compliance with expedited reporting timelines. Management acknowledged these points and committed to future compliance.