483
Atlas Spine, Inc.FDA 483 - Atlas Spine, Inc. - July 19, 2019
Record Details
An FDA inspection of Atlas Spine, Inc., a medical device manufacturer in Jupiter, FL, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for complaint handling, process controls for orthopedic instruments, and employee training. These issues indicate a lack of robust quality management practices.
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ID · 3371e6a3-2661-4764-8da0-c92dbf0207c0