Texas Device Manufacturer, Sterilizer Draws FDA Warning
The FDA sent a warning letter to American Contract Systems for process validation violations at its Houston, Texas medical device manufacturing and sterilizing facility.
An agency inspection revealed that the sterilization operations were not adequately validated to demonstrate that all component materials, sizes, solutions and types could undergo and withstand the sterilization process.
For example, the process challenge packs it used for sterilization did not represent the facility’s routinely sterilized components in each product family and there was no data to support its selection of worst-case components used in the packs.
The agency also warned the firm for not having procedures to monitor and control process parameters to ensure that the specified requirements continue to be met.