FDA Cites Michigan Firm for Sterile Environment Control Deficiencies

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.