Cetro America Inc. – FDA 483, Feb 1, 2024

Cetro America Inc. in Meriden, CT, was issued a Form 483 with three observations following an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including the absence of written Medical Device Reporting (MDR) procedures, inadequate complaint handling processes, and insufficient control over purchased products and services from contract manufacturers. These issues highlight a fundamental lack of established and implemented procedures critical for medical device manufacturing compliance.