FDA EIR - MSD International GmbH (Puerto Rico Branch) LLC - February 21, 2018

An FDA inspection of MSD International GmbH (Puerto Rico Branch) LLC, located in Las Piedras, PR, was conducted from February 1 to February 21, 2018. The inspection, covering quality, production, facilities, equipment, and laboratory systems, identified significant deficiencies under the Food, Drug, and Cosmetic Act, particularly regarding Good Manufacturing Practices (GMP). The main violations, documented on an FDA Form 483, included the absence of adequate process controls to address variability in the Sitagliptin active ingredient within Janumet XR Tablets, leading to multiple lot rejections. Investigators also noted the repeated presence of coliform bacteria in water systems used for manufacturing non-sterile drug products and cleaning equipment, indicating insufficient microbial control. Furthermore, the facility failed to prevent pest and insect ingress into manufacturing areas. Management was informed of these objectionable conditions and committed to submitting a written response within fifteen working days. The inspector emphasized that without adequate corrective actions, these observations could be escalated to formal violations, underscoring the necessity for the firm to implement robust changes to ensure product quality and regulatory compliance.