Inspections, Compliance, Enforcement, and Criminal Investigations
Biolase Technology, Inc. 05-Sep-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
September 5, 2006
Jeffery W. Jones
Biolase Technology, Inc.
Irvine, CA 92618
Dear Mr. Jones:
During an inspection of your establishment located in Irvine, California, on August 8 through August 17, 2006, our Investigator determined that your firm manufactures and markets medical and dental lasers. These products are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), because they are intended for use in the cure, treatment, prevention, or diagnosis of a disease or medical condition, or affect the structure or any function of the body.
The above-stated inspection revealed that these devices are adulterated under section 501(h) of the Act, 21 U.S.C. 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:
1. Failure to ensure that management with executive responsibility has established and controls an adequate and effective quality system that is fully implemented and maintained at all levels of the organization as required by 21 CFR 820.20 and 820.22. Specifically, your quality system requires an internal quality audit on an annual basis. There was no internal quality audit performed from September 2004 until February 2006 but your management review procedure requires the results of the internal audit as an input to the meeting. There were two management review meetings in 2005 (04/26/05 and 07/27/05) 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.
2. Design output procedures do not allow for an adequate evaluation of conformance to design input requirements as required by 21 CFR 820.30(d). Specifically, the software requirement input specifications for the Waterlase MD dental laser could not be individually verified and documented to show conformance to the corresponding functional outputs.
3. Procedures were not completed to ensure that the device design was correctly transferred into production as required by 21 CFR 820.30(h). Specifically, the design transfer procedures have not included explicit instructions to transfer the software requirement specifications to production. The software requirement specifications for the Waterlase MD design project were not transferred to production in November 2004 when most other specifications and procedures were transferred. Finished Waterlase MD dental lasers began to be commercially shipped in December 2004, but the software requirements were not transferred to production until April 20, 2005.
4. Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified as required by 21 CFR 820.90(a). Specifically, statistical analysis of field returns involving the delivery system (trunk fibers, handpieces, and tips) in early 2005 for the Waterlase MD caused you to initiate a CAPA project, # 07050501, to reduce these delivery system problems. This CAPA remains open while at least two more delivery system related CAPAs, # 06020 and 06030, dated 03/23/2006 and 08/04/2006, respectively, have been initiated because Waterlase MD delivery system problems are still occurring.
5. Not all complaints have been reviewed and evaluated to determine whether an investigation is necessary as required by 21 CFR 820.198. Specifically, there at least 325 customer complaints dating back to 10/13/2005 that have not been evaluated to determine if an investigation is necessary.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the Food and Drug Administration (FDA). You also must promptly initiate permanent corrective and preventive action on your quality system.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket approval applications for Class III devices to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
If you have any questions relating to this letter please contact Senior Compliance Officer, Dannie E. Rowland at 949-608-4448. You may obtain general information about all of FDA's requirements for manufacturers of medical devices through the Internet at http://www.fda.gov.
Please submit your response to:
Pamela B. Schweikert
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2445
Alonza E. Cruse
Los Angeles District Office