FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Virginia Devicemaker Slammed for Nonconforming Procedures

Jan. 28, 2019

The FDA cited Fairfax, Virginia device manufacturer LC Technologies for lacking written procedures for nonconforming devices and other issues identified in an Oct. 2-5, 2018 inspection.

The investigator found that the firm lacked adequate procedures for corrective and protective actions and for finished device acceptance. In some cases, final testing documentation was not signed and dated.

In addition, the facility failed to document complaints upon receipt as required by its written procedures.

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