FDA 483 - Dexcowin Co. Ltd. - August 31, 2017

An FDA inspection of Posdion Co. Ltd. in Seoul, Korea, a manufacturer of portable X-ray systems, from August 28-31, 2017, revealed extensive deficiencies across its quality system. The firm lacked adequately established procedures for critical areas such as design validation, process validation, software validation, corrective and preventive actions, complaint handling, purchasing, servicing, device history records, training, document control, management review, and quality audits. Furthermore, the company failed to report an accidental radiation occurrence as required.