Inspections, Compliance, Enforcement, and Criminal Investigations
Telex Communications, Inc. 23-May-05
Department of Health and Human Services
Public Health Service
Kansas City District
May 23, 2005
RETURN RECEIPT REQUESTED
Ref. KAN 2005-09
Mr. Raymond P. Malpocher
President and CEO
Telex Cornmunications, Inc.
12000 Portland Avenue South
Burnsville, MN 55337
Dear Mr. Malpocher:
During an inspection of your establishment located in Lincoln, Nebraska, on March 23 to April 1, 2005, United States Food and Drug Administration (FDA) investigators determined that your establishment manufactures auditory trainers. Auditory trainers are devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The investigators documented significant violations from the Quality System (QS) regulation, Title 21, Code of Federal Regulations, Part 820, and the Medical Device Reporting regulations, Title 21 CFR, Part 803. These violations cause the devices you manufacture to be adulterated within the meaning of Section 501(h) [21 U.S .C . 351(h)] and misbranded within the meaning of Section 502(t)(2) [21 U.S.C. 352(t)(2)] of the Act.
Quality System Regulation
The investigators noted the following violations of the QS regulation:
Your firm fails to establish and implement procedures to maintain Device History Records (DHR) for each batch, lot, or unit to demonstrate the device is manufactured in accordance with the Device Master Record (DMR) and the Quality Systems regulation, as require by 21 CFR 820.184. There are no written procedures established to ensure the Device History Records for the Telex Select 2-40 FM Receiver/Hearing Instrument indicate it's manufacture in accordance with the Device Master Record and other requirements of the Quality Systems regulation.
Your firm fails to maintain Device History Records for the Telex Select 2-40 FM Receiver/Hearing Instrument, as required by 21 CFR 820.184 in that
The date of manufacture is not contained or referenced in the Device History Record for the Telex Select 2-40 FM BTE device, as required by 21 CFR 820.184(a). The manufacturing date is found in the Serial Number Log but there is no reference to this. Log in the Device History Record;
Your firm fails to maintain copies of acceptance test results in the Device History Record, as required by 21 CFR 820.184(d). The results of finished device testing are shipped to device customers; and
The primary label and labeling issued with each device manufactured are not included in the Device History Record, as required by 21 CFR 820.184(e).
Medical Device Reporting (MDR)
Your devices are misbranded within the meaning of Section 502(t)(2) in that your firm failed to comply with a requirement prescribed under Section 519 of the Act respecting the devices as follows:
Your firm fails to develop and maintain written MDR procedures, as required by 21 CFR 803.17. You have no written Medical Device Reporting procedures for the following prescription medical devices: the Telex Select 1-40 FM BTE device, and the Telex Select 2-40 FM BTE device.
Your firm fails to establish and maintain MDR event files, as required by 21 CFR 803.18(a). Your firm has no MDR event file.
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 Form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your establishment's quality system. You are responsible for investigating and determining the causes of the violations identified by the FDA.
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 submissions for Class III devices to which the Quality System/GMP deficiencies are reasonably related will be cleared or approved until the violations have been corrected. Also, no requests for Certificates to Foreign Governments will be approved 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil penalties.
We are aware of your plans to discontinue manufacture of the Telex Select 1-40 FM BTE and the Telex Select 2-40 BTE by the end of 2005 at the Lincoln location. While these devices may no longer be manufactured at the Lincoln plant, any future device manufacturing at this location will require compliance with the Quality System Regulations for medical devices.
Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be complete, (2) any documentation indicating that corrections have been achieved, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur.
Your response should be sent to Joseph G. Kramer, Compliance Officer, Food and Drug Administration, at the address noted in the letterhead
John W. Thorsky
Kansas City District