Synovo Adulterated, Misbranded Products

A 10/11-10/26/22 FDA inspection at Synovo Production in Fullerton, CA, determined that the firm is the specification developer, manufacturer, and distributor of a femoral resurfacing cup that is distributed as a standalone product and as part of a total hip system. A 3/23 Warning Letter says the firm received 510(k) clearance for the femoral cup in 1991.

FDA says that since that clearance, the cup has been significantly changed or modified in design, components, method of manufacture, or intended use multiple times, but the company has not submitted a new 510(k) for it, thus rendering it adulterated.

The letter lists additional reasons why the products are adulterated and misbranded and then lists Quality System Regulation violations:

• failing to validate according to established procedures where results of a process cannot be fully verified by subsequent inspection and test;
• failing to establish and maintain procedures to control the design of the device to ensure that specified design requirements are met;
• failing to establish procedures for implementing corrective and preventive action;
• failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
• failing to document the dates and results of quality system reviews by management with executive responsibility;
• failing to conduct quality audits; and
• failing to document personnel training.

The letter also notes that the company has not been registered and listed with FDA.

While the company said it would provide a formal response within 15 business days of the close of the inspection, FDA says it had not received the response by the date of the Warning Letter.

Synovo was told to immediately cease manufacture of the total hip system and femoral resurfacing cup and take prompt action to correct the violations in the letter.

It was told to respond with a list of specific actions it has taken to address the noted violations and prevent them from occurring again, with documentation of the corrective actions, and a schedule for completing the corrections.

The letter concludes that the violations listed in the letter and on the form FDA-483 issued at the close of the inspection “may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.”