FDA 483 - Clinicon Corp - April 19, 2018

An FDA inspection of Clinicon Corp, a Class II Medical Device Manufacturer in Oceanside, CA, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes, document equipment calibration and maintenance, and maintain proper records for supplier evaluations, incoming product acceptance, and device history. Additionally, Clinicon Corp did not submit required annual reports for their Class IV laser product.