German IVD Maker Hit With 483 For Quality Control Procedure

Viramed Biotech, a German manufacturer of in vitro diagnostics, received a one-observation Form 483 related to an issue with its quality control procedure.

According to the recently released form, the company’s quality control procedure for release and final control requires it to test cut antigen strips with a precharacterized panel of qualified serums listed on a data sheet. However, around Aug. 13, 2012, the company ran out of a serum that was part of the panel, but continued to test and release product for distribution until the time of the inspection.

The Form 483 includes another nearly identical issue associated with a slightly different procedure number.

Viramed Biotech did not respond to a request for comment by press time.

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