483
Legend Spine, LLCFDA 483 - Legend Spine, LLC - August 08, 2019
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Record Details
An FDA inspection of Legend Spine, LLC in Bethlehem, PA, revealed two significant quality system deficiencies. The firm failed to conduct required quality audits and did not perform management reviews of the quality system at defined intervals, both as stipulated in their own Quality System Manual. These observations indicate a lack of adherence to established internal quality procedures.
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ID · 7a4f7c13-3a2d-4928-be11-f816b0fda617