FDA Warns Device Manufacturer, Sterilizer in Texas

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.

A review of the facility’s device master records showed that critical component specifications for sterilization processing were not identified for its top five selling sterilized surgical trays, an issue the agency also flagged during a previous inspection. The agency found that the five trays were sterilized using processes that had not been validated.

Read the American Contract Systems warning letter here: www.fdanews.com/12-06-19-AmericanContractSystemsWL.pdf.