FDA WARNING_LETTER - Dongguan Rainbow Tech Electronic & Plastic Products Co., Ltd - July 11, 2025

The FDA issued a Warning Letter to Dongguan Rainbow Tech Electronic & Plastic Products Co., Ltd. on October 7, 2025, following an inspection from July 10-11, 2025, at their Dongguan, China facility. The inspection found that the company"s Class II manual emergency ventilators (Bag Valve Mask devices) were adulterated because their manufacturing processes did not conform to the Quality System regulation (21 CFR Part 820), as mandated by the Federal Food, Drug, and Cosmetic Act.

Key violations included the failure to establish adequate procedures for monitoring and controlling process parameters for validated processes, specifically noting a lack of process control at a manufacturing station. The company also failed to validate critical manufacturing processes, such as for a component of the Pocket Bag Valve Mask, where results cannot be fully verified by later testing. Furthermore, the firm neglected to document equipment calibrations for essential machinery and exhibited deficiencies in its document control procedures, including the use of uncontrolled forms and improper corrections on records.

While Dongguan Rainbow Tech submitted planned corrective actions, the FDA could not determine their adequacy due to the absence of supporting documentation or evidence of implementation. The company is required to implement these corrective actions and provide concrete proof to the FDA to demonstrate compliance with regulatory standards.