SweetSpot Slapped With Form 483 for Alleged Follow-up Issues
The FDA cited a diabetes device data firm for alleged procedural failings in a recent FDA Form 483.
The post-inspection finding for Portland-based SweetSpot Diabetes Care concluded that the devicemaker did not adequately investigate reported product variances and did not investigate multiple complaints about product failings fully.
The inspector’s first concern regarded product nonconformities that were documented in SweetSpot’s Corrective and Preventive Action records, with three of 19 failing to document an investigation into the cause of the product nonconformity. Two of those flagged also were cited for omitted verification of any corrective actions taken as a result, as was a third CAPA.
According to the 483, these nonconformities included “certain customers unable to use the system,” test dates that did not always align with pre-populated dates in the forms, signatures omitted from scans of documents, real-time stamps not being available and customers having difficulty downloading product files from the company’s website.
The inspector’s second concern was the lack of evidence that the company conducted investigations into two customer complaints.
According to the 483, the company received complaints regarding one customer supposedly receiving an erroneous report and another customer that apparently uploaded data to SweetSpot that was “dated in the future.” Neither of these appears to have been adequately investigated.
SweetSpot promised to correct both failings, the 483 shows.
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