FDA 483 - Boston Scientific Corporation - August 25, 2005

This FDA Form 483 document details observations from an inspection, highlighting several deficiencies related to medical device reporting (MDR) and quality system procedures.

A primary finding is the failure to submit MDR reports within 30 days of becoming aware of information suggesting a marketed device caused or contributed to a death or serious injury. Specifically, 66 such reports were not submitted within the 30-day timeframe between January 2004 and June 2005. Similarly, 36 MDR reports for device malfunctions, which would likely cause or contribute to death or serious injury if recurring, were also not submitted within 30 days during the same period. The document notes that these issues were "promised to correct."

Further, complaints representing MDR-reportable events were not promptly reviewed, evaluated, and investigated by a designated individual. From January 2004 to June 2005, 46 events were filed late as MDR reports due to human error, with the company promising correction.

The procedures for implementing corrective and preventive actions (CAPA) were not implemented, as a CAPA was not initiated for the recurring issue of late MDR report submissions. This was also "promised to correct."

Finally, procedures for the acceptance or rejection of finished device production runs, lots, or batches were incomplete. The Relative Humidity specification range was established more broadly than the actual applied process range, and procedures did not describe steps to take if this