Post-approval inspection of Sigmedics grows.

Sigmedics, Chicago, IL, Chicago District.

Just three months after FDA approved its Parastep I spinal-cord stimulator in April 1994, Sigmedics was visited by agency inspectors from July through October 1994.

The EIR said that the Center for Devices requested the inspection in order to obtain a catalogue of labeling and promotional materials, examine records regarding device-related injuries, check for MDR compliance, find out how many devices were in distribution and see whether Sigmedics had issued safety alerts or recalls. No recalls had occurred prior to the inspection, but the EIR said that one did take place before the inspection was over, involving a battery charger made by a subcontractor.

The device was approved to enable selected persons with mature spinal cord injuries to stand and attain limited ambulation and or to take steps following physical therapy, the PMA summary of safety and effectiveness (Doc. 104521) said.

As time went on, the 1994 inspection became more comprehensive than CDRH's list of requests.

Investigator Colleen Aspinwall compiled a 19-point 483, including some objections still left from the preapproval inspection performed in December 1993. At that time, the Chicago District recommended against PMA approval, the EIR continued.

The October 1994 EIR zeroed in first on quality assurance, with Aspinwall finding no evidence of production record review before distribution, or of necessary feedback for the quality assurance unit to respond to QA problems.

In the complaint area, FDA found that the firm was not documenting all telephone communications involving problems and concerns, the EIR stated. The inspection further determined that the company had failed to follow its own procedure for documen-tation of complaints.

In addition, the document said that while 33 device-related problems appeared

in the PMA, complaint records showed nearly twice that many. The EIR included the company's explanation that complaints received by the service and repair department had not been communicated to the person who listed such occurrences in the PMA.

Complaint problems extended to MDR issues, with Aspinwall noting that Sigmedics did not get enough information to make a decision on whether to report to FDA. The firm argued that none of its complaints were MDR reportable, the EIR said.

The investigator's look at failure investigations netted two more objections, including failure to document the reason for not performing an investigation and failure to investigate reports of blown fuses to ascertain what caused them.

Change controls caught FDA's attention as well, with the agency finding signature/approval blocks removed from change notice forms. According to the EIR, the company stated that these forms were actually reconstructed records, with change approved verbally and the forms filled in later. This practice was the subject of a second change-control item in the 483.

Sigmedics disagrees with FDA on validation

The agency also faulted process validation, finding that while wave soldering was tested and visually inspected, there was no evidence proving that these practices were adequate. Sigmedics took the position that the testing and inspection made validation unnecessary, the EIR stated.

The company disagreed again when the FDA called their electro-static discharge (ESD) program unvalidated. According to Sigmedics' comments in the EIR, the standards used for ESD controls constituted validation.

Wave soldering appeared again in two complaints in the 483, finding that wave solder samples were not collected on schedule and that maintenance of the equipment was not documented.

The investigator cited three problems with the device master record, finding a lack of required information, changes were made by a subcontractor without the knowledge or approval of Sigmedics, and obsolete documents.

Company comments in the EIR explained this last item as the result of changes underway in the document control system.

Device history records came under fire, too, with the report noting that device history records were maintained only for some components. Aspinwall further noted that a history record suggested failure to follow an SOP for a battery pack burn-in period.

A final 483 item took a look at an SOP for failure reporting, which required a report for any failure detected during various tests. However, no such reports were maintained, the documents said.

The EIR touched on two matters discussed but left out of the 483 -- the adequacy of quality assurance personnel and the importance of vendor audits. Aspinwall expressed concern that the person in charge of quality assurance also oversaw production.

As for the vendor audits, Aspinwall pointed out that the battery charger recall was the kind of thing that could be prevented by assuring vendor adherence to procedures and specifications.

A written response submitted by Sigmedics in November 1994 promised corrective actions in all areas, including improvements to procedures and documentation, better adherence to existing procedures, development of an approach to the requested process validations and collaboration with subcontractors to ensure GMP compliance.

Sigmedics, Chicago, IL 7/28/94-10/17/95, 107422M, $23.50 plus handling. PMA summary for Parastep I, $33.50 plus handling.