FDA EIR - Merck Sharp & Dohme LLC - September 06, 2019

Merck & Company in Rahway, NJ, underwent an FDA inspection from August 26 to September 6, 2019. This inspection was a follow-up to a 2015 Official Action Indicated (OAI) inspection that identified issues with data availability, screening data, protocol adherence, and monitoring for a clinical study (NDA #22-225). Guided by Compliance Program 7348.810 for Sponsors, the 2019 visit evaluated Merck's corrective actions for the prior deficiencies. The main observation noted during the current inspection was Merck's failure to notify the FDA of the for-cause closure of a foreign clinical investigator site involved in Clinical Study # (b)(4), as required by 21 CFR 312.56(b). During the close-out meeting, Ms. Deborah Driscoll, VP for Merck Research Laboratories Quality Assurance, accepted the Form FDA-483. Merck is required to investigate this oversight and submit a written response to the FDA within 15 business days. No other significant deficiencies were noted, and no samples were collected during this inspection.