DEVICE MANUFACTURER WARNED FOR NOT PERFORMING REQUIRED TESTS
Dupaco violated current good manufacturing practices by not performing required tests or following complaint procedures with its blood/fluid warming sets, according to an FDA warning letter.
Dupaco's products are adulterated, said the Nov. 21 warning letter, which was posted recently to the agency website. The company had responded to the agency's Form 483, but the response was insufficient because it did not include all the requested documentation, according to the letter.
The warning letter cited Dupaco for failing to test complaint samples. The company also did not conduct annual burst, creep and sterility tests to verify the package integrity of its blood/fluid warming sets, as is required.
Further, Dupaco lacked documentation explaining the predetermined cycle time used in the heat-sealing processes and did not provide a statistical rationale to justify the sampling method used in functional tests required for finished goods inspections.