FDA 483 - Microcare Medical - August 29, 2019

Certol International, LLC, a manufacturer of chemical sterilants in Commerce City, CO, received a Form 483 with seven observations following an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate complaint handling, nonconforming product control, and corrective and preventive action processes. Further issues were noted in process validation, equipment calibration, incoming product acceptance, and device master record maintenance, indicating a broad lack of robust controls.