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FDA Warns Korean Device Maker After Follow Up Inspection

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to South Korean medical device maker Won Industry Co. LTD last August, citing the firm for deficiencies related to its corrective and preventative action (CAPA) procedures, complaint handling and device history records.The warning letter comes after FDA inspected Won's Siheung-si facility in April 2019, which was a follow up to an earlier inspection in October 2015 that resulted in the company receiving a Form 483, followed by a warning letter in December 2016.According to FDA, Won failed to investigate the root cause of all deficiencies identified in its CAPAs stemming from the earlier inspection."Not all distributed products, complaints, CAPAs, and other quality system issues that potentially have been affected by these quality system deficiencies have been analyzed to identify existing and potential causes of nonconforming product, or other quality problems," FDA writes.FDA also cites the company for its deficient complaint handling procedures, which do not require evaluating complaints or recording unique device identifiers or complainants' phone numbers and addresses in complaint investigation records. FDA notes that this is a repeat observation from the 2015 inspection.In another repeat observation, FDA says that Won did not have a written device history record procedure for two models of its Morning Life Compression Limb Therapy System and "it was discovered that [the] firm does not include a primary identification label or unique identifier (UDI) of the finished devices" for its device master record (DMR).FDA points out that the company's monitoring system procedures do not discuss electronic submission of medical device reports, despite FDA requiring the electronic submission of such reports since August 2015.Due to the issues cited in the warning letter, FDA says it is refusing entry of the company's devices into the US and is placing the company on Import Alert 89-04 for detention without physical examination of devices from firms that have not met device quality system requirements.