FDA Sends Warning Letter to Texas Device Sterilizer
The US Food and Drug Administration (FDA) sent a warning letter to the Houston site of the medical device manufacturer and sterilizer American Contract Systems after raising questions about complaints related to bugs found inside supposedly sterile bags.During the inspection last September and October, FDA said it observed that six out of 12 complaints reported between 2017 and 2019 were related to bugs on the inside of sealed sterilized bags, and in one of the instances a surgery was delayed.
The letter notes how the surgical packs are assembled, packaged and prepared for sterilization at the firm and stored in a warehouse before being packaged for sterilization. “There is no indication that your raw material packaging area is listed as a controlled environmental room,” FDA says.
FDA also says it observed that the firm’s sterilization operations have not been adequately validated to demonstrate that all component materials, sizes, solutions, types, etc., can undergo and withstand the company’s sterilization process and methods.
“During our review of your device master records (DMR), critical component specifications for sterilization processing activities were not identified for your top five (5) selling [redacted] sterilized surgical trays,” FDA says.
And the agency found no documented evidence that component materials that are sterilized, such as PVP solution, catheter, stopcock, band bag, suction tubing, gowns, etc., “were represented based on worst-case components by product families in your most recent sterilization validation summary report (VSR-TX-003) dated July 2017,” FDA adds.
The warning letter also notes a repeat observation from a previous FDA inspection in March 2011 related to 21 CFR 820.181.
In November 2018, FDA sent a warning letter to the company's Pennsylvania-based site after saying the company provided “unacceptable” timelines to correct other inspectional observations.
Warning Letter