Inspections, Compliance, Enforcement, and Criminal Investigations
Gyrus ENT, LLC 13-Nov-06
Department of Health and Human Services
Public Health Service
New Orleans District
November 13, 2006
WARNING LETTER NO. 2007-NOL-04
Robert L. Hoxie, President/CEO
Gyrus ENT, LLC
2925 Appling Road
Bartlett, Tennessee 38133-3901
Dear Mr. Hoxie:
On August 14-23, 2006, a United States Food and Drug Administration (FDA) investigator inspected your facility, Gyrus ENT, LLC, located at 2925 Appling Road, Bartlett, Tennessee. The investigator determined your firm manufactures the Diego Hand Piece intended for general nose, throat, and head/neck procedures. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 United States Code (USC) 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. You may find guidance and more information regarding FDA regulations through links in FDA's internet home page at http://www.fda.gov. and in the National Archives and Records Administration internet page at http://www.gpoacess.gov\cfr\retrieve.html.
The inspection revealed these devices are adulterated within the meaning of Section 501(h) of the Act, [21 USC 351(h)], because the methods used in, or facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from you dated August 24, 2006, concerning our investigator's observations noted on Form FDA 483 (FDA 483), List of Inspectional Observations issued to you. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for identifying the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, in 2004 and 2005, your firm initiated a product improvement project to improve the reliability of the Diego Hand Pieces by changing front and rear seals. This action was taken because of a mean-time failure rate of 48% trended from complaints received in 2002 through 2003. After the changes to the front and rear seals were made, complaints continued at a mean-time failure rate of 23.4%. In this situation, a Corrective and Preventative Action (CAPA) is necessary because product changes must be validated and complaints associated with the devices should be monitored under the CAPA system to prevent the recurring problems.
We have reviewed your response to this observation and have concluded it to be inadequate. Your response refers to a memorandum dated December 1, 2005, which was provided to the FDA investigator during the inspection. The December 1, 2005, memo states a CAPA is unnecessary because device improvements have resulted in a decline of Diego Hand Piece complaints and your firm is confident the complaint history will support the effectiveness of design changes. However, without a CAPA, your firm may fail to detect and prevent recurring quality problems which may be causing device failures identified in the complaints.
2. Failure to establish and maintain procedures for the identification, documentation, and validation or verification of design changes before their implementation, as required by 21 CFR 820.30(i). For example, your firm implemented design changes to improve failure rate and reliability of the Diego Hand Piece involving the selection of new front and rear bearings (implemented November 2004) and design of new front and rear seals (implemented January 2005). The changes were not included or validated in design controls.
We have reviewed your response to this observation and have concluded it to be inadequate because the documentation you provided with your response is part of the product design evaluations conducted by the R & D as part of the product improvement project to improve the reliability of your device. Prior to implementing the changes, your firm must validate whether the changes will adversely affect the device.
3. Failure to analyze reports from quality data sources to identify existing and potential causes of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(1). For example, prior to November 2005, your firm did not include service reports as complaints.
We have reviewed your response to this observation and have concluded it to be inadequate. Your response notes your firm is currently analyzing and trending service records for potential CAPAs. However, your firm has not reviewed all of the service records prior to November 2005 to determine whether there were additional complaints or trends.
4. Failure to adequately validate and approve, according to established procedures, a process for which results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example; [redacted] adhesive is applied to the outer housing of front and rear bearings during the Diego Hand Piece assembly and cured in the oven for [redacted]. This process has not been validated to ensure the will hold parts in place after being cured in the oven.
We have reviewed your response to this observation and have concluded it to be adequate.
5. Failure to establish and maintain design output procedures to ensure design outputs which are essential for the proper functioning of the device are identified, as required by 21 CFR 820.30(d). For example, the user's manual fails to describe the frequency in which a Diego Hand Piece must be sent to the service center for routine maintenance. You stated during the inspection there is a one-year warranty on the Diego Hand Piece and, after the one-year warranty expires, normal wear and tear could cause the device to require service. However, there is no reference in the user's manual of need for service. Instead, the user's manual discusses only regular cleaning after each use and sterilization techniques.
We have received your response to this observation and have concluded it to be inadequate. Your response states the Diego Hand Piece is not classified as a device which requires routine maintenance by the service center. However, your firm has failed to determine whether the recommended care and cleaning practices, which are identified in the user's manual, have a direct affect on the life of the Diego Hand
The last validation was conducted on November 11, 2003, to review the effects of repeated cleaning and sterilizing using an autoclave, which was a simulation of the procedure recommended in the user's manual. But the bearings, seals, gear shaft, and motor were not included in the study. During the inspection, your firm guaranteed motors would be autoclave and the autoclave did not effect bearings and seals. However, you have failed to determine whether the device will function properly as a result of regular care and cleaning practices recommended in the user manual and failed to determine the frequency in which the device would need to be returned for
service to prevent failures.
6. Failure to establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptance of process capability and product characteristics, as required by 21 CFR 820.250(a). For example, as of August 21, 2006, the procedure for statistical techniques did not define which statistical methods are used for generation of trending corrective and preventative data, complaint and nonconforming reports used in management review, and other quality management reports.
This observation appeared to be adequately corrected during the inspection.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct violation(s) 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 they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
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 violation(s), or similar violation(s), from recurring. Include documentation of 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 timeframe within which corrections will be completed.
Your response should be directed to the U.S. Food and Drug Administration, Attention: Kimberly L. McMillan, Compliance Officer, 404 BNA Drive, Building 200, Suite 500, Nashville, Tennessee 37217. If you have any questions about the content of this letter, please contact Ms. McMillan at (615) 366-7811.
Finally, you should know 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 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 causes of the violations and take prompt actions to correct violations to bring your products into compliance.
H. Tyler Tsshornburg
New Orleans District