QS Issues at American Contract

An 8/5-8/14 FDA inspection at Owens & Minor, doing business as American Contract Systems, in Mechanicsville, VA, found Quality System Regulation violations in the firm’s manufacturing of sterile convenience kits such as a C-Section Pack. An 11/1 Warning Letter says the specific violations were:

• failure to establish and maintain procedures for acceptance of incoming product to ensure that incoming product is inspected, tested, or otherwise verified as conforming to specified requirements, and that acceptance or rejection is documented; and
• failure to establish and maintain procedures to control the design of the device to ensure that specified requirements are met.

The letter says the firm’s responses to the inspection observations were inadequate.

American Contract was told to act promptly to address the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.