483
Colorado Therapeutics LLCColorado Therapeutics LLC – FDA 483, Aug 21, 2019
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.
View Company Profile
ID · e6f55554-709b-4669-bc49-3e2e24e7a464
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.