FDA 483 - ChiRhoClin, Inc - September 15, 2025

ChiRhoClin, Inc. in Burtonsville, MD, was inspected by the FDA and received a Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, including inadequate stability testing programs, deficient laboratory records, and a lack of proper change control procedures. These issues indicate a systemic failure to maintain robust quality management systems for drug product manufacturing and testing.