BioGenex Labs, San Ramon, CA, July 27 (San Francisco).(MEDICAL DEVICES)

During an FDA investigation of BioGenex conducted from Feb. 1 through March 9, the agency determined that the manufacturer of pathology related stains, antibodies and in vitro diagnostic test kits was not in conformance with current GMP requirements of QS regulations for medical devices. Significant deviations included, but were not limited to the following.

BioGenex was cited for failure of management with executive responsibility to ensure that an adequate and effective QS had been fully implemented and maintained at all levels of the organization; failure to control products that did not conform to specifications; failure to establish procedures for the control of finished devices to ensure that only devices approved for release were distributed; and failure to establish procedures to control the design of the device to ensure that specified design requirements were met.

Furthermore, FDA pointed out that the manufacturer had not established procedures for conducting quality audits, and had not established C-H procedures to assure that oral complaints were received, reviewed and evaluated by a formally designated unit. For example, according to the warning letter, BioGenex failed to enter into its C-H system, reports from field representatives indicating they were experiencing false-positives when using the firm's InSite HER-2/neu as directed.

Finally, FDA pointed out that BioGenex had neglected to establish adequate procedures for identifying training needs and documenting personnel training to ensure that all personnel were trained to adequately perform their assigned responsibilities. Specifically, the agency noted, the personnel that performed testing on the InSite HER-2/neu antibody and the InSite HER-2/neu kits were not trained to the approved QC testing procedures.

The agency acknowledged written response letters from BioGenex, dated March 30 and May 25, but concluded that the responses were inadequate because the specific documentation to demonstrate the implementation of CAPA had not been provided by the company. CAPA, C-H, OOS, QC/QS; Doc. 13922W