Contract device manufacturer Valtronic netted a Form 483 for inadequate CAPA procedures, nonconforming products and a failure to document validations at its Solon, Ohio plant.
The FDA, which inspected the facility from Dec. 12-19, 2018, said Valtronic was not using nonconformance data as a quality data source for its CAPA system or analyzing the data for potential corrective and preventive actions.
At least two CAPAs were opened in 2017 to address delamination issues, but both were not completed and did not address investigative activities. One was closed as “unsuccessful,” while the other had no further action taken at all.
The firm’s process validation activities and results were also found to be lacking as they failed to include equipment variables and other key criteria. For example, there was no record of who conducted validation activities and durability studies were not conducted.
The agency also found that the manufacturer’s nonconforming product procedure was incomplete. Specifically, the company didn’t include defects found on one of the lines during manufacturing.
Read the 483 here: www.fdanews.com/03-28-19-aaltronictechinc483.pdf.