Curia New Mexico, LLC – FDA 483, Apr 11, 2022

Curia New Mexico, LLC, a sterile drug product manufacturer in Albuquerque, New Mexico, received a Form 483 with 13 observations following an FDA inspection. The observations highlight significant deficiencies across process validation, environmental monitoring for mold, investigation practices, aseptic processing, component identification, laboratory controls, microbial risk assessments, cleaning and sanitization programs, data integrity for electronic systems, utility qualification, equipment maintenance, and quality unit oversight of contractors. These issues indicate a broad lack of adequate controls to ensure the sterility, quality, and purity of drug products.