FDA 483 - Blue Chip Medical Products, Inc. - March 18, 2019

This FDA Form 483 was issued to Blue Chip Medical Products, Inc. in Suffern, NY, following an inspection on March 18, 2019. The inspection revealed significant deficiencies in the firm's quality system, specifically the absence of written procedures for Medical Device Reporting (MDR) and corrective and preventive actions (CAPA). These observations indicate fundamental gaps in the firm's regulatory compliance.