Siemens Healthcare Gets 483 for CAPA, Complaint Handling

The FDA handed Siemens Healthcare Diagnostics a Form 483 for violations including inadequate documentation of corrective actions and substandard complaint-handling procedures.

The 483, issued April 23, 2014, says a CAPA was submitted following customer complaints of abnormal calibrator reactions for several lots of Dimension Vista Chol Flex Reagent, used to evaluate lipid status and metabolic disorders. The cause was identified as too low cholesterol oxidase activity because of improper refrigeration. To correct the problem, additional cholesterol oxidase was added as needed during the manufacturing process.

Siemens implemented a field action against the affected lots, but did not investigate the supplier to evaluate material variability of the manufacturing process beyond the storage temperature requirements. The 483 followed an inspection of the company’s Newark, Del., facility.

Analysis Performed Improperly

The FDA also chided the company over its complaint handling. According to the investigator, product support specialists analyzed complaints after pulling data from the common complaint-handling system. However, the analyses weren’t performed according to written and approved procedure.

In addition, information used to capture and record incoming calls and complaints was not uniformly and consistently entered in the complaints database, the form says, citing instances of lot numbers and serial numbers entered in the wrong data fields.

Company spokesman John Gillespie said that each of the observations in the 483 has been addressed and fully documented with the FDA.

Despite many fewer FDA inspections of devicemakers over the last three years, the number of 483s issued to companies rose 12 percent and warning letters skyrocketed 24 percent. That's why the timing couldn't be better for you to take advantage of the FDAnews management report Device Supplier Controls: Avoiding an FDA Form 483.