Five-item 483 issued to Biolase.(Medical Devices)

Several deficiencies were found during an Aug. 8-17, 2006, inspection of dental laser manufacturer Biolase. FDA investigator James Fleckenstein recorded complaint handling procedures and a lack of quality assurance at the company's Irvine, CA, site.

The inspector cited Biolase for failure to conduct annual internal quality audits as required, noting that no audit had been conducted from September 2004 through February 2006. "There were two management review meetings in 2005 that should have noted the lack of an internal audit but there was no prompt action taken by Executive Management to initiate an internal audit," Fleckenstein wrote.

In its response to the 483 Biolase stated that it had taken steps to improve management oversight of its quality system and "to prevent the recurrence of the issues cited in this observation."

The company reported that it had hired a new head of quality assurance in January 2006 who immediately conducted "a full assessment of the company's quality system for compliance with applicable laws and regulations," which was completed in February 2006.

Biolase also established an internal quality system audit schedule that "is currently being diligently followed," and a second internal quality audit was ongoing, the response letter stated. Further, Biolase had revised its management review procedures to include "a more complete management review checklist. and had conducted training on the procedure.

The FDA investigator also found that the company's software requirement input specifications for the Waterlase MD dental laser "could not be individually verified and documented to show conformance to corresponding functional outputs," he wrote. In response to this observation, the company replied, Biolase revised its design control procedure and forms to "require a review of the software requirements matrix at phases one through four." Under the new procedure each phase incorporated a requirement for final review by the firm's quality assurance unit.

Fleckenstein also observed that the company's design transfer procedures had not included explicit instructions to transfer the software requirement specifications to production. He noted that finished Waterlase MD lasers "began to be commercially shipped in December 2004, but the software requirements were not transferred to production until April 20, 2005."

In response, Biolase again undertook revisions to its design control procedures to ensure the procedure "provides the method for specification transfer to production." Training on the procedure had also been conducted, the company added, and "an expanded internal audit of our design history files. was performed to ensure that all software requirements matched the newly implemented changes to standard procedures.

The inspection found that a CAPA Biolase had opened to reduce delivery system problems with the Waterlase MD remained open while two additional CAPAs were initiated "because Waterlase MD delivery system problems are continuing." The company explained in its response that the original CAPA was opened to identify the root cause of "a higher than expected failure rate of the Waterlase MD delivery system."

Through this CAPA, the company "defined and implemented both design and process improvements which reduced the field failure rate of the Waterlase MD." This CAPA was closed Sept. 18, 2006. Another CAPA was opened that related to "an increased rate of trunk fiber failures," which was being addressed through a six sigma process, while the third CAPA related to "an increased number of handpiece issues," which was in process at the time of the inspection.

Fleckenstein had noted in the 483 that "there are at least 325 customer complaints dated back to 10/13/2005 that have not been evaluated to determine if an investigation is necessary." Biolase explained in its reply that before April 7, 2006, the firm's "complaint process automatically treated any field service activity as a complaint."

However, the company had revised its complaint system "to create an objective evaluation of all field service activity to determine whether or not they qualified as complaints. under FDA regulations. Since that time, the company wrote, "all of our complaints have been reviewed and, as necessary, investigated and closed. All future complaints will be addressed, investigated and closed. in accordance with regulation and the firm's procedures.

FDA notified Biolase that its response had been found adequate in addressing the observations noted on the 483. Biolase Technology, Irvine, CA, 8/8-17/06, Doc. 110125M, $12.50 plus retrieval

Checklist: Biolase Technology

[check] Infrequent quality audits

[check] Unresolved CAPAs

[check] Unevaluated customer complaints

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