FDAnews Device Daily Bulletin

FDA Hits Innovative Sterilization Technologies on CAPA, Complaints

July 31, 2017

Problems with Innovative Sterilization Technologies’ CAPA procedures, complaint handling and MDR processes earned the devicemaker a Form 483.

The FDA issued the form following an April/March inspection of the firm’s Dayton, Ohio, facility. Investigators noted numerous problems with the facility’s CAPA procedures. The company SOPs had no clear definition of “unfavorable trend,” and the company failed to initiate a CAPA in response to trends that required one according to the SOPs.

The facility’s complaint SOP, meanwhile, did not properly define how to document investigations and complaint closures for cases where the device was not returned for evaluation. The company voided nearly 50 complaints because the product was never returned.

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