The FDA issued a warning letter to Thermedx, a Solon, Ohio-based manufacturer of gynecological and urological fluid management systems, for failing to notify the agency of device upgrades and other GMP violations.
According to the April 8 letter, Thermedx made 21 software upgrades to its System P4000 between April 2010 and October 2013, in response to reported hazards such as incorrect calculation of fluid deficit on the device canister. Although all of the upgrades were assigned a “10,” Thermedx’s highest hazard severity level, the firm didn’t submit written notification of the actions within the required timeframe.
The investigator also notes that between April 2011 and April 2014, Thermedx released at least six software upgrades to eliminate or reduce the likelihood of fluid measurement deficiencies, but didn’t properly notify the FDA.
Further, the company’s device history records didn’t indicate that the product met requirements and was manufactured in accordance with the master record. A review of 17 DHRs for the fluid management system showed that six didn’t conform to required pressure specifications and eight devices weren’t tested.
Thermedx’s validation plan also came in for a hit because it didn’t ensure that process results could be verified by subsequent inspection. The company deviated five times from fixed values for its ultrasonic welding process, which is used to manufacture cartridges, and some complaints could be attributed to the welding process, the warning letter says.
The letter also chides the firm for its evaluation and control of suppliers. For example, the investigator found no evidence of review or acceptance of validated processes used by critical suppliers to manufacture components for the system. The devicemaker’s purchasing control procedures also didn’t describe methods and frequency of monitoring suppliers.