Fendental MFG Slapped With 483 for Procedural Deficiencies
The specification developer and initial importer based in Medley, Fla., drew a Form 483 from the FDA for procedural issues, including complaint handling, after an inspection in December.
The firm did not have a purchasing control procedure or recorded evaluation of its contract manufacturer and own-label product suppliers, making it unable to ensure products and services it received conform to specifications.
It also failed to implement its acceptance procedure for receipt, sampling and storage of products. The firm did not document incoming acceptance activities for any finished devices received.
Fendental also had an inadequate complaint handling procedure. It did not require investigation of events that must be reported to the FDA, including the assessment of whether a device failed specifications; whether the device was used for treatment or diagnosis; and any relationship of the device to the event. Its record retention period for complaint files was also inadequate, the agency said.
In addition, one of the firm’s medical device reporting procedures did not require the electronic submission of MDR event reports.