FDA WARNING_LETTER - Contec Medical Systems Co., Ltd. - June 12, 2025

The FDA issued a Warning Letter to Contec Medical Systems Co., Ltd. following an inspection conducted from June 9-12, 2025, in Qinhuangdao, Hebei, China. The inspection revealed that the company"s medical devices, including patient monitors and ultrasound systems, were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 351(h)) for failing to conform with the Quality System regulation (21 CFR Part 820).

Key violations included inadequate procedures for corrective and preventive actions (CAPA), specifically in investigating nonconformities, documenting corrective actions, and verifying their effectiveness. The firm also failed to adequately establish and maintain procedures for device design validation, with deficiencies in test plans, test reports, software design documentation, and risk management. Furthermore, the company lacked adequate procedures for receiving, reviewing, and evaluating complaints, particularly from e-commerce sites and international officials, and did not maintain accessible records, especially for third-party validation. Additionally, CMS8000 Patient Monitors were found to be misbranded under 21 U.S.C. § 352(t)(2) due to issues related to corrections and removals.

The FDA deemed the company"s initial responses inadequate, requiring systemic implementation of revised procedures, retroactive reviews of past activities like CAPAs and complaints, and comprehensive evidence to demonstrate full compliance and the effectiveness of all corrective actions.