Inspections, Compliance, Enforcement, and Criminal Investigations
Dornier Medtech America, Inc. 01-Jun-07
Department of Health and Human Services
Public Health Service
Atlanta District Office
June 1, 2007
VIA FEDERAL EXPRESS
Dornier Medtech America, Inc.
1155 Roberts Boulevard, NW
Kennesaw, Georgia 30144-3617
Dear Mr. Walsh:
During an inspection of your firm located in Kennesaw, Georgia on February 20 through March 5, 2007, our investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures laser fiber cables sold for use in laser systems for endourology procedures. Under section 201(h) of the Federal Food, Drug,and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Our inspection revealed that your laser fiber cables are misbranded under section502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
1) Failure to submit MDR reports within 30 calendar days after the day that you received or otherwise became aware of information, from any source, that reasonably suggests that a device that you market has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21CFR 803.50(a)(2). For example:
a) Ten complaints of fiber tip breaks were correctly assessed as being reportable events during your corrective and preventive action (CAPA) review in preparation for FDA's pre-announced inspection (i.e., CAPA Form Number 07-001, dated February 16, 2007. The ten complaints areas follows: 1-05-084, dated August 30, 2005; 1-06-008, dated February 24, 2006; 1-06-014, dated March 20, 2006; 1-06-015, dated April 3, 2006 1-06-018, dated April 11, 2006; 1-06-025, dated May 18, 2006; 1-06-026; dated June 5, 2006; 1-06-035, dated September 18, 2006; 1-06 044, dated July 28, 2006; and 1-06-049, dated September 14, 2006). The events were subsequently reported to FDA more than 30 calendar days after having received the complaint reports.
b) Two additional complaints of fiber tip breaks (#1-05-072, dated July 7,2005 and #1-06-027, dated June 6, 2006) were determined not reportable by your firm. However, because your firm has reported instances of serious injury occurring from the same fiber tip break malfunctions in the past (e.g., #1037955-2003-00005 and #1037955-2003-00006), these two complaints should have been reported as malfunctions.
We have reviewed a response to the Inspectional Observations, Form FDA 483 (FDA 483), from Mr. Tim Thomas, Vice President QA/RA/Clinical, dated March 23, 2007, and have concluded that it is inadequate because the MDR reports submitted to FDA on February 21 and March 8, 2007, were not submitted within 30 calendar days of the date your firm became aware of the malfunctions.
2) Failure to develop, maintain, and implement written MDR procedures for internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, that provide for a standardized review process or procedure for determining when an event meets the criteria for reporting under Part 803, that provide for the timely transmission of complete medical device reports to manufacturers and FDA, and procedures to document and maintain records of medical device reports and information submitted to the manufacturer, as required by 21 CFR 803.17. For example:
a) Your firm's procedures for evaluating and investigating complaints and requirements for MDR reporting, defined in QSP-005, Complaint Handling Procedure and QSP-010, Medical Device Reporting, are not adequate in that they do not contain standardized review processes for determining when an event meets the criteria for reporting. Our review of your complaint files revealed that 17 of the 35 complaints reviewed were not correctly evaluated as being MDR reportable to FDA. In addition, a February 16, 2007, company directed CAPA document (CAPA Form Number 07-001), signed by Mr. [redacted] indicates that several complaints should have been submitted as MDRs. Your root cause analysis revealed that your complaint and MDR reporting procedures should have been updated following your correspondence with FDA, dated January 13, 2005. Also, FDA suggested additional revisions to your complaint and MDR reporting procedures in a March 8, 2005, letter. No revisions to your procedures were made to address FDA's concerns.
b) Complaint #1-06-014 (MDR #1037955-2007-00003) was of a fiber tip breaking off into a patient's kidney during device use. There is no documentation of patient outcome. In addition, documentation within the complaint file states your firm became aware of the event in the form of a letter, but the letter was not maintained within the complaint file.
We have reviewed Mr. Thomas, March 23, 2007, response to the FDA 483. The response acknowledges that an FDA 483 was issued to your firm at the conclusion of an FDA inspection on August 27, 2004, which identified similar MDR-related observations about fiber tip breakage complaints. In response to that FDA 483, representatives of your firm met with FDA's Atlanta district office on December 15,2004. In follow-up to that meeting, Mr. Thomas wrote a letter to FDA, dated January 13, 2005, outlining your firm's analysis of MDR reporting of typical fiber tip complaints FDA responded, in a letter dated March 8, 2005, advising you of our determination that all malfunctions (fiber tip breaks) are reportable. Mr. Thomas asserts that your firm did not receive this letter, and therefore did not revise your firm's written MDR procedures. As a result of this past inspection and most recent FDA 483, Mr. Thomas requested another meeting with the agency to further discuss your MDR reporting procedures. In sum, we acknowledge the history of communication with the agency on this issue. Nevertheless, we conclude that your response to this violation is inadequate because your written MDR procedures do not meet the requirements of the regulation.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, 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.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation, or similar violation, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. 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.
Your response should be sent to the attention of Philip S. Campbell, Compliance Officer, Food and Drug Administration, Atlanta District, 60 Eight Street, NE, Atlanta, GA 30309. If you have any questions about the content of this letter please contact Mr Campbell at (404) 253-1280.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Mary Woleske, Director
cc: Dave Eng, President/CEO
Dornier MedTech Asia Pte, Ltd.
51 Corporate Road