Siemens Healthcare Diagnostics fell short on CAPA procedures, acceptance activities and equipment maintenance, the FDA said in a Form 483 issued the form after a February/March inspection of the devicemaker’s East Walpole, Massachusetts, facility.
FDA officials found the company failed to verify the effectiveness of three CAPAs and its investigations of deviations or out-of-specification results observed during quality control acceptance activities were not properly documented, the agency said.
The FDA also faulted the Siemens facility for not properly verifying the accuracy of the reagent expiration dates its software calculated and generated.
Lastly, according to the FDA, the company produced no documentation for preventive equipment maintenance activities performed in its controlled temperature rooms, including coolers and freezers used for storage, handling and processing of products.
Read the Siemens Healthcare Diagnostics Form 483 here: www.fdanews.com/08-02-18-siemenshealthcarediagnosticsinc483.pdf. — Zack Budryk