Lack of Defined Quality Assurance Procedures Land Infimed a Form 483

April 23, 2012
Infimed, a maker of software and specialized hardware for medical imaging, does not always review all acceptance records and packaging checklists before releasing product for shipment, a Form 483 for the company’s Liverpool, N.Y., plant states. The site lacks complete procedures to define the responsibility and authority to approve and release product for shipment, FDA investigators note. Further, quality data in the form of complaints are not adequately handled.
The GMP Letter