Sterile devices were handled in a cleanroom with inadequately defined environmental controls, FDA inspectors found in an inspection of a Centurion Medical Products facility in Howell, Michigan.
The manufacturer of catheters and other surgical equipment also lacked a validation process for sealing a sterilized product. The company said that a validation was previously completed for a similar product, but the agency investigators noted it did not use the same packaging material.
The FDA officials also noted that airborne particulate monitoring results exceeded the action limit on two occasions, but the investigation was not fully documented.
In addition, the firm did not perform testing using worst-case conditions and its CAPA procedures were inadequate, the agency said.
Read the Centurion Medical Products Form 483 here: www.fdanews.com/12-06-19-centurionmedicalproductscorp483.pdf.