An FDA inspection of Southwest Technologies’ Kansas City, Missouri-based facility in February and March uncovered 13 observations, most relating to quality system failures and failure to track nonconforming products and submit Medical Device Reports.
The manufacturer of sterile wound dressings received two reports of frostbite in association with its hypothermia caps, mittens and slippers, but the events were not documented and MDR reports were not submitted even though one patient reportedly lost three fingers, the Form 483 said.
The firm’s sterilization validation for stimulen collagen wound dressings did not meet acceptance criteria, and the verification study method did not include provisions for retesting of samples, the FDA said.
The FDA discovered that the firm had not established design control procedures, and a device master record was not maintained. Procedures and specifications for manufacturing were not established for any of the firm’s medical devices.
The facility also failed to document corrective and preventive actions activities. For example, CAPAs were not opened during 2015 and 2016, even though the firm withdrew products from the market and instituted a full quality management system reboot in 2015.
Procedures to control nonconforming products were not established, the investigator said, and management reviews were not performed from July 15 to December 2017. The company had not appointed a management representative to oversee quality system activities, and it failed to document training activities.
The manufacturer also fell short in controlling environmental conditions. The firm’s cleanroom was cleaned in response to fungus and bacteria positives reported by an outside vendor during a laboratory safety and controlled environment test on Dec. 18, 2017. But the cleaning activities were not documented.
Finally, the firm had not established procedures for identifying product during all stages of receipt, production, distribution and installation, the FDA said, noting that there was no written procedure for generating finished product lot codes.