Repeated complaint handling violation results in 6-item 483 for MicroSurgical Tech.

MicroSurgical Technologies, Redmond, WA, Bothell, WA, District

An uncorrected complaint-handing problem led to a six-item 483 being issued to MicroSurgical Technologies, Redmond, WA. Conducting the audit from the Bothell, WA, District Office was investigator Deborah Nebenzahl.

The 483 stated that complaint-handling procedures were not defined to ensure that all complaints were processed in a uniform and timely manner. The report referenced eight separate reports that were not processed or reviewed on time. This was a repeat observation from the previous FDA inspection conducted Oct. 17, 2003.

The firm's response read: "Of the eight RMA numbers cited, five were closed prior to the inspection and were closed in a timely fashion. Some of these RMAs may have been characterized as open based on the status of a related CAPA."

Next, FDA documents faulted MicroSurgical because appropriate sources of quality data were not adequately analyzed to identify existing and potential causes of nonconforming product and other quality problems.

The firm replied that it believed that its quality system "has been designed and constructed to ensure that sources of quality data are monitored and analyzed. MicroSurgical systematically collects data on all sources of quality data. The methods for coping with these types of exceptions includes immediate correction, risk assessment and escalation criteria."

Regarding comments on internal audits, the company noted the audit procedures at the firm until mid-2005 included a corrective action pathway that was separate from the general CAPA flow. Audit findings and the associated corrective/preventative actions from the period through mid-2005 were not visible within the CAPA historical log.

Another repeat violation FDA noted was: "The firm does not have a mechanism for identifying existing or potential causes of quality problems through their internal quality audits."

Further, the report stated that not all actions needed to correct and prevent the recurrence of nonconforming product and other quality problems were identified. For example, the investigation conducted as part of CAPA request No. 392 did not include documented analysis of the scope of the issue to include whether multiple components, devices or lots were affected by the contamination found.

Also, the investigation conducted as part of CAPA 425 did not include documented analysis of the scope of the issue to include whether multiple components, devices or lots were affected by the failure of the EDM process.

In addition, the investigation conducted as part of CAPA 448 did not include documented analysis of the scope of the issue to include whether multiple components, devices or lots were affected by the expired sterilization certificate.

CAPA procedures also were inadequate, the report stated, because CAPA activities were not documented, including investigations of causes of nonconformities, the actions needed to correct or prevent recurrence of nonconforming product and other quality problems, the verification or validation of corrective actions and implementation of corrective and preventive actions.

Specifically, several CAPAs did not include documentation of corrective and preventative activities, including investigation of causes of nonconformities, actions needed to correct or prevent recurrence, implementation and verification or validation of corrective and preventative actions, as well as risk analysis.

For example, the following CAPAs lacked documentation of CAPA activities:

* CAPA 285--Lacked documentation for implementation and verification or validation of CAPA actions, as well as risk analysis that could have affected indications for use or safety; and

* CAPA 425--Lacked documentation including investigation of nonconformity, the scope of actions needed to correct or prevent recurrence, as well as documentation for implementation, and verification or validation of corrective and preventative actions, and risk analysis that could have affected indications for use or safety.

The company replied: "CAPA 285 is an open CAPA and for that reason, does not contain documentation for implementation and verification or validation of corrective and preventative actions. The issue is the lack of a formal method for providing QA reference samples for use in inspection. An informal method has been successfully used to provide reference samples, but the method has not been documented, keeping the CAPA open."

The firm stated that CAPA 425 was triggered as a result of a rejection of seven parts in a manufacturing batch for a single defect attribute. The suspect parts were detected and scrapped. "The defect in question is highly detectable, and other lots were not implicated by these defects. The process involved in producing the attribute in question is part specific, thus no other components or devices were implicated," the letter noted.

The company was not available for comment. MicroSurgical Technologies, Redmond, WA, 11/8-21/05, Doc. 109920M, $10 plus retrieval.