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

An FDA inspection was conducted at Merck & Co Inc in Summit, NJ, from June 10 to June 14, 2013. The inspection was a high-priority pre-approval bioequivalence data validation of the sponsor's bioanalytical laboratory. It focused on the bioanalytical portion of study P05615, supporting NDA 205-053, which investigated the pharmacokinetics and safety of posaconazole. The inspection followed the In Vivo Bioequivalence, CPGM 7348.001 regulatory framework, emphasizing verification of study records against submitted data and assessment of the analytical method's accuracy and robustness. Merck's Summit facility, which previously housed the bioanalytical laboratory, had been decommissioned in October 2011, with operations moved to other locations. The inspection involved reviewing practices, personnel qualifications, method validation, study testing procedures and records, laboratory notebooks, and sample handling documentation. Notably, the inspection concluded with no objectionable conditions observed, and a Form FDA-483 (Inspectional Observations) was not issued. The inspection was classified as "No Action Indicated" (NAI). While a consumer complaint regarding a foreign object in an over-the-counter product (Coricidan HPB Flu Tablets) manufactured by Merck Canada was noted, it was not related to the bioequivalence study. Merck had investigated this complaint but could not determine a root cause and stated they would continue monitoring such complaints. No specific regulatory actions were required from Merck related to the primary scope of this bioequivalence inspection.