MSD International GmbH (Puerto Rico Branch) LLC – FDA EIR, Feb 26, 2020

An FDA inspection of MSD International GmbH (Puerto Rico Branch) LLC, a manufacturer of solid drug products, was conducted from February 5 to February 26, 2020, in Las Piedras, PR. The inspection covered quality, facilities and equipment, materials, production, and laboratory systems, aligning with compliance programs for drug manufacturing. The inspection verified that issues identified in a previous February 2018 inspection, which included inadequate process controls for Janumet XR content uniformity, coliforms in water systems with associated control and cleaning procedure failures, and pest presence in manufacturing areas, had been adequately corrected. However, the current inspection revealed new deficiencies. Specifically, the company failed to conduct thorough investigations in both laboratory and manufacturing areas. Furthermore, the firm did not issue Field Alert Reports (FARs) within the required three business days. Consequently, an FDA Form 483, detailing these objectionable conditions, was issued to the Plant Manager, Ms. Livia Y. Cruz. The identified violations fall under the regulatory framework of the Food, Drug and Cosmetic Act, necessitating prompt corrective actions from the company to address these findings and ensure compliance with good manufacturing practices.