FDA 483 - Perma Laboratories LLC - June 08, 2018

Perme Laboratories LLC, a re-packer/re-labeler in Hinckley, OH, received a Form FDA 483 with 10 observations. The inspection revealed widespread deficiencies in the firm's quality system, including a lack of established procedures for corrective and preventive actions, non-conforming product control, complaint handling, medical device reporting, supplier control, document control, equipment calibration, quality audits, and labeling activities. These issues indicate a fundamental failure to implement and maintain a compliant quality system for medical devices.