Regulatory Focus™ > News Articles > Warning Letter Claims South Korean Device Company Failed to Implement Promised Changes

Warning Letter Claims South Korean Device Company Failed to Implement Promised Changes

Posted 07 February 2013 | By Alexander Gaffney, RAC

A South Korean medical device company is at the receiving end of a particularly blunt warning letter in which US regulators accuse the company of fixing almost none of the problems they found during a 2010 inspection.

The 26 November 2012 letter to Seoul-based Sometech Incorporated, manufacturer of medical imaging equipment and high-frequency surgical instruments, references an April 2012 inspection by the US Food and Drug Administration (FDA).

During that inspection, regulators said they observed a number of quality failures sufficient enough to cause the firm's devices to be adulterated under US federal law.

Among the litany of allegations categorized by FDA inspectors are device malfunction reports not considered as complaints, corrective and preventive actions not taken after quality failures, failure to properly maintain a device history file or conduct regulator audits.

Inspectors also highlighted what they said were failures to properly train staff. In one alleged case, they said they found a copy of a build work sheet posted above an employee's work station. A subsequent investigation found that employee was unqualified to assemble that particular subcomponent and was not trained in the company's quality policy either.

But more than the present problems-relatively par for the course for most warning letters sent to device manufacturers as of late-was the company's history with FDA inspectors, the warning letter explained.

"We note that we also inspected your facility on 1 November 2010, through 4 November  2010," FDA wrote. "That inspection resulted in an 11-item Form FDA 483 [inspection report]," which FDA uses to outline deficiencies found at a facility in need of correction. "Observations 1, 2, 3, 4, 5, 6, 8, 9, and 10 were not corrected. CAPAs were not completed for these observations."

"Changes were made to your firm's procedures," FDA said, "But there was no evidence of implementation. Deficiencies in files and records for these observations were not corrected."

FDA said the company will "remain on import alert" until all violations are both corrected and verified during the course of a follow-up inspection.

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