St. Jude has been handed a two-observation Form 483 related to its investigation procedure and supplier controls.
The company investigated the root cause of damaged coils in its IsoFlex silicone leads, identifying the use of an unapproved tool as one of the sources of the nonconformance. However, the investigation did not provide evidence for why an unapproved tool was used in manufacture, or how long it had been in use, the form says.
St. Jude also identified a specific operator as a source for the nonconformance but did not document why other operators that used the same tool were not investigated.
And the company lacks a timeline requirement for how long its suppliers have to respond to or complete corrective actions related to SCAR requests. The procedure allows the supplier to apply for extensions on corrective actions and there are no limits to the number of extensions, the form says.
Two CAPAs opened in late 2012 and related to device malfunctions were awaiting supplier corrective actions at the time of the FDA’s April 23 to May 7 inspection, the Form 483 says.
The company did not provide a comment on the form.
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