Home » Virginia Devicemaker Slammed for Nonconforming Procedures
Virginia Devicemaker Slammed for Nonconforming Procedures
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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