FDA EIR - Merck & Co Inc - June 14, 2013

An FDA inspection was conducted at Merck & Co Inc's Summit, NJ facility from June 10 to June 14, 2013. The primary objective was a high-priority pre-approval bioequivalence data validation of the sponsor's bioanalytical laboratory. This inspection, carried out under the regulatory framework of In Vivo Bioequivalence, CPGM 7348.001, aimed to verify data for study P05615, which supported New Drug Application (NDA) 205-053 for posaconazole. The inspection focused on the bioanalytical portion of the bioequivalence study, including personnel qualifications, training records, method validation, study testing procedures and records, laboratory notebooks, and sample handling documentation. Crucially, the FDA inspection concluded with no objectionable conditions observed. Consequently, a Form FDA-483 (Inspectional Observations) was not issued, and the inspection was classified as "No Action Indicated" (NAI). No refusals were encountered, and no samples were collected. While an unrelated consumer complaint concerning a foreign material in an over-the-counter product (Coricidin HPB Flu Tablets) was reviewed, it was distinct from the bioequivalence study scope, and Merck indicated ongoing monitoring without further direct action from this specific inspection finding. No specific required actions were identified for Merck as a result of this inspection.