483 Roundup: FDA Cites Four Device Firms
The FDA issued Form 483 reports to devicemakers in Oregon, California and Colorado.
Dental Components: A devicemaker’s manufacturing facility in Oregon was cited for closing customer complaint investigations without documenting the changes identified for addressing the issues or verifying their effectiveness.
An FDA investigator reviewed eight complaints of Dental Components’ distributed medical devices during a September 2017 site inspection and found that four of them listed corrective actions, but their effectiveness had not been documented. Issues reported in the complaints include a barb coming out of the Autoclavable Premium Saliva Ejector swivel assembly, and threaded tips not screwing off.
The facility also lacked certain adverse event reporting procedures and requirements. It had not specified situations that would reasonably suggest a device malfunction would be likely to cause or contribute to a death or serious injury if it were to reoccur, as well as requirements for ensuring timely MDR submissions to the FDA. Out of the eight closed complaints, five had not been evaluated to determine whether they met the criteria as MDR-reportable events.
The agency also found deficiencies in the firm’s procedures for maintaining device history records. A total of 11 records out of 13 selected did not include required information, including initials and dates, from personnel who released the devices for distribution.
Zeus-MJB: An FDA site inspection at Zeus-MJB’s manufacturing facility in California revealed several noncompliance issues associated with its quality management systems.
As of late September 2017, the firm did not have procedures for executive management to conduct routine reviews of its quality system in order to ensure compliance with established policies. The facility also lacked procedures for performing internal quality audits.
There was also no plan defining the practices, resources, and activities for designed and manufactured devices to meet quality requirements, and management had not established policies and objectives for committing to quality manufacturing, the agency said.
In addition, the firm had “not completed any evaluations to select potential suppliers, contractors, and consultants on the basis of their ability to meet specific requirements, including quality requirements,” and did not maintain records for those deemed acceptable.
The facility also lacked procedures for complaint handling, acceptance and verification activities, as well as adverse event reports.
Multisource Manufacturing: Multisource Manufacturing drew a Form 483 for failing to adequately establish or validate various procedures at its Colorado medical device facility, the FDA found in a November site inspection.
The FDA investigator observed that the facility had not validated its automated milling and lathing processes. In addition, the instruments, which the firm used to manufacture its blunt tips and linear probes, did not have all of their parts verified.
The firm was also cited for inadequately establishing procedures for accepting and controlling in-process product. Specifically, it had been using an inadequate procedure for monitoring and measuring products. The firm had not documented in-process inspection requirements, and failed to perform an in-process measurement for length as required by established specifications.
CAPA procedures were also flagged as they lacked requirements for work operations, analyzing processes and other sources for obtaining quality data, and an analysis of data used to track quality management system effectiveness was found to have a lack of defined limits or actions taken to correct issues.
Good Clean Love: 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 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.”
The firm also failed to document complaint analyzes for the Almost Naked Lubricant device until Sept. 22, 2017.
Other Form 483 observations related to inadequate procedures controlling documentation and design verification, as well as a lack of procedures for design changes and a device master record.
Read the Dental Components Form 483 here: www.fdanews.com/01-05-18-dentalcomponentsllc483.pdf.
Read the Zeus-MJB Form 483 here: www.fdanews.com/01-05-18-zeusmjbinc483.pdf.
Read the Multisource Manufacturing Form 483 here: www.fdanews.com/01-05-18-multisourcemanufacturingllc483.pdf.
Read the Good Clean Love Form 483 here: www.fdanews.com/01-05-18-goodcleanloveinc483.pdf. — Ana Mulero