483
Blue Chip Medical Products, Inc.Blue Chip Medical Products, Inc. – FDA 483, Feb 18, 2022
Record Details
An FDA inspection of Blue Chip Medical Products, Inc. in Suffern, NY, revealed deficiencies in their quality system. The firm failed to maintain written Medical Device Reporting (MDR) procedures and lacked an electronic submission account. Additionally, critical standard operating procedures were not properly approved with dates and signatures from upper management.
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ID · a8c75c36-78c9-41d1-9d5f-7cf5ce8df41a
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