The FDA flagged TJN Manufacturing in a Form 483 for problems with quality, CAPAs and production processes.
In an April inspection of the device manufacturer’s Davenport, Iowa facility, the agency found the firm lacked the required quality system procedures for producing medical devices. Moreover, the company had not properly established procedures to ensure design changes were properly documented and reviewed.
The company has also failed to create a device history record showing its class two device met critical specifications and user requirements, and the facility did not maintain documentation relating to each unit’s manufacturing and release. Moreover, the company had not developed work instruction and final production check lists to ensure that all devices were manufactured according to specifications.