FDA warns Chinese and Swiss device makers over quality system violations

The US Food and Drug Administration (FDA) recently published three warning letters it sent to medical device manufacturers in China and Switzerland over quality system and current good manufacturing practices (CGMP) violations.

The two Chinese companies, Dongguan Rainbow Tech Electronic & Plastic Products Co. and FC Company Limited, produce bag valve masks, which are used to provide respiratory support to patients in respiratory distress or who are not breathing; the third company, LEVO AG manufactures various standup wheelchairs.

Dongguan Rainbow Tech

Dongguan Rainbow Tech, a manufacturer of Class II pocket bag valve mask devices based in Guangdong Province, China, was cited for four GMP violations.

FDA said the company failed to establish adequate procedures for monitoring and controlling process parameters for a validated process. “The process parameters were not adequately monitored, nor were they adequately documented in either the daily set up log, or batch records,” said the warning letter.
The agency criticized the company for not validating the manufacturing process of a component in the device. Additionally, the firm was cited for lacking documentation on equipment calibrations.
FDA also cited the firm for inadequate document control procedures. “Several forms were being used without the required Form Number, Document Number, or Revision Level, including the Internal Audit Meeting Attendance Sheet and the Management Review Meeting Attendance Sheets for 2023 and 2024. Additionally, the use of liquid correction fluid, which is prohibited by your firm's record control procedures, was observed on a Device History Record,” FDA wrote.

FDA gave the company 30 days to correct the violations noted in the warning letter.

FC Company Limited

FDA issued a warning to FC Company Limited, a device maker based in Hong Kong, China, for CGMP violations in the manufacturing of its Pocket BVM (bag valve mask).

The agency said the company failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. For example, there was no formal process for documenting complaints.

The company also failed to establish and maintain document control procedures. “For example: ‘FC-Test Report Checklist,’ a form used to document critical secondary quality inspections, is not managed under the firm's established document control system,” FDA wrote.

The firm was given 30 days to correct the violations noted in the warning letter.

LEVO AG

FDA also warned LEVO AG after inspecting its plant in Wohlen, Switzerland. The company manufactures the LEVO C3, LEVO Combi, LEVO LAE, and LEVO LCEV standup wheelchairs, which are classified as Class II devices.

Investigators said the company failed “to establish and maintain a quality system that is appropriate for the specific medical devices designed and manufactured as required by 21 CFR 820.5.”

For example, the FDA stated that the company has not established a quality system in accordance with 21 CFR Part 820, which includes necessary quality system procedures and instructions. The firm also lacked documentation to demonstrate management responsibility and did not provide documentation related to quality audits.

“You did not have documentation to establish requirements for Personnel, including background, training, and experience, per 21 CFR 820.25,” said the warning letter.

FDA said the company also did not have proper documentation for design controls or requirements for product identification.

In addition, the company failed to adequately develop, maintain, and implement written medical device reporting procedures.

The agency said that “given the serious nature of the violations,” the agency is “taking steps to refuse entry of these devices into the United States until these violations are addressed.”

Dongguan Rainbow; FC Company; Levo AG

FDA warns Chinese and Swiss device makers over quality system violations

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