FDA Inspection Passed with Flying Colors

The FDA conducted a preannounced routine surveillance inspection to evaluate CTI’s compliance with 21 CFR Part 820, FDA’s Quality System Regulations and 21 CFR Part 803, FDA’s Medical Device Reporting Regulations. Surveillance inspections are conducted to monitor the manufacturing process and the quality of FDA regulated products on the market. The agency uses the inspection to evaluate whether a manufacturer is complying with quality manufacturing practices.   At the conclusion of the inspection, no FDA-483s nor Inspectional Observations were issued.