483
Colorado Therapeutics LLCFDA 483 - Colorado Therapeutics LLC - August 21, 2019
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Record Details
Colorado Therapeutics LLC, a medical device manufacturer in Louisville, CO, was cited for deficiencies in its quality system. The inspection revealed that procedures for device history records were not adequately established, leading to issues with tracking and accounting for finished goods and samples. This indicates a lack of robust manufacturing control and record-keeping practices.
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ID · e6f55554-709b-4669-bc49-3e2e24e7a464