The FDA handed Italian devicemaker Canè 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 Canè’s Rivoli-Turino, Italy, plant.
The FDA also dinged Canè 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. Canè’s corrective and preventive action procedures also were deemed inadequate, as they didn’t describe how the company would evaluate all sources of quality data to identify existing and potential nonconforming product.
The FDA chides the company for not establishing and maintaining adequate procedures for quality audits. The firm’s quality audit procedure requires auditors to be independent, but the firm allowed an assistant quality manager to audit an area without appropriate background or training to assess firmware verification or validations. The company’s 483 response failed to include an updated quality audit procedure, the letter says.