483
180 Innovations LLC180 Innovations LLC – FDA 483, Jan 29, 2020
Record Details
An FDA inspection of 100 Innovations LLC, a repackager/relabeler in Lakewood, CO, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures and documentation for complaint handling, rework of nonconforming products, statistical techniques for process control, and device history records. These issues indicate a systemic lack of adherence to quality system regulations.
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ID · e7275a2b-6c46-4d37-8d96-eb02954bde41
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