Complaint handling and CAPA procedures were flagged at Good Clean Love’s Oregon manufacturing facility during a September 2017 FDA site inspection.
A total of 20 customer complaints that the firm had marked as investigated since 2016 were reviewed by an agency investigator. Seven of them did not include a lot coding for each device and the firm lacked documentation of any attempts to obtain the coding.
None of the 20 complaints had any documentation on whether they had been evaluated to determine if they should be reported to the FDA as adverse events. The firm also failed to document complaint analyzes for the Almost Naked Lubricant device until Sept. 22, 2017.
The investigator observed that CAPA procedures were inadequate at the time of the inspection in that they did not include processes for analyzing quality data that could help to identify any issue other than nonconforming product. One in three of the firm’s CAPA actions that had been implemented since 2015 “was not fully implemented and the effectiveness of the activities was not documented.”