IV SET MANUFACTURER CITED FOR CONTROL PROCEDURE
Command Medical Products' purchasing control procedure was "inadequate" because the firm did not evaluate suppliers' and contractors' adherence to the quality system regulation, said a recent FDA warning letter.
For example, the company uses a contractor to produce tubing for its Command Huber Infusion Set, but "failed to determine if the inner/outer diameter of the tubing is altered by the heat used during [the] sterilization process."
Because of such failures, the device is adulterated, the FDA said.
The IV set manufacturer received the warning letter on Aug. 17, after an inspection in May. The letter was posted to the FDA website earlier this month. The letter described other firm violations, including:
Failure to analyze complaints, returned product and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems; and
Failure to document process validation monitoring and control methods, the results of which cannot be fully verified by subsequent inspection and test.
To view the letter go to www.fda.gov/foi/warning_letters/g6001d.htm (http://www.fda.gov/foi/warning_letters/g6001d.htm).