Cane S.p.A Hit With Warning Letter Over Infusion Pump

The FDA handed Italian devicemaker Cane S.p.A. a warning letter for not including a software validation procedure in a Form 483 response, after the agency determined that production of the Crono S-PID-50 infusion pump did not comply with current good manufacturing practices.

According to the July 29 letter, the company didn’t have a protocol for performing code testing on software used to control infusion pumps and didn’t document test results, including a list of software defects found during code testing.

The 483 and warning letter followed a Feb. 16 to 19 inspection of Cane’s Rivoli-Turino, Italy, plant.

The FDA also dinged Cane for failing to establish procedures for receiving and reviewing complaints. For example, 26 of 30 repair and maintenance report records of primary immunodeficiency pumps reviewed during the inspection stemmed from complaints, but there was no evidence the complaints were investigated or evaluated for MDR reporting. Cane’s response didn’t include how it planned to revise its complaint procedures, the letter says.

Cane’s corrective and preventive action procedures were also deemed inadequate, as they did not describe how the company would evaluate all sources of quality data to identify existing and potential nonconforming product. The company failed to provide a discussion of updated CAPA procedures or a retroactive analysis of repair data in its response to the 483, the warning letter says.

Cane did not respond to a request for comment by press time.

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