Inspections, Compliance, Enforcement, and Criminal Investigations
IOPI Northwest Company, LLC 25-Jun-08
Department of Health and Human Services
Public Health Service
June 25, 2008
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 08-23
Erich S. Luschei, Manager
IOPI Northwest Company, LLC
5901 Tolt River Road NE
Carnation, Washington 98014-6202
Dear Mr. Luschei:
During an inspection of your firm located at 5901 Tolt River Road NE, Carnation, Washington, on February 20 and 22, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Iowa Oral Performance Instrument (IOPI), described in your User Manual (January 2008) as intended to measure tongue strength and fatigability and hand strength and fatigability. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
The inspection of your facility revealed that these devices are adulterated within the meaning of 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 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.
These violations include, but are not limited to, the following:
1. Your firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA) as required by 21 CFR 820.100(a). Your firm has never initiated corrective or preventive actions and you have not established CAPA procedures.
2. Your firm failed to establish procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). You have not established procedures for handling complaints even though you have been manufacturing the IOPI.
3. Failure to establish and maintain procedures to ensure that the device history records (DHR's) for each batch, lot, or unit are maintained in order to demonstrate your firm's medical devices are manufactured in accordance with the device master record as required by 21 CFR 820.184. You are not maintaining your device history records to include acceptance activities to ensure that your product meets the design specifications. In addition, your records do not show any testing performed as well as procedures that must be fully documented and include all review and approval of finished devices.
4. Your firm failed to establish procedures for quality audits and conduct such audits and to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. You have been manufacturing and distributing the IOPI without any procedures for conducting a quality audit. Also, you have never conducted a quality audit.
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. 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 these violations, or similar violations, 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 Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about the content of this letter please contact Lisa M. EIrand at (425) 483-4913.
In addition, it has come to our attention that, on your website (http://www.iopi.info/fag.htm), you state, "The IOPI is registered with the FDA, but it is not 'approved' because the FDA does not approve medical devices." These statements are incorrect. First, establishments, not devices, are registered with FDA, as set forth in section 510 of the Act (21 U.S.C. 360). For more information on Registration and Listing, see http://www.fda.gov/cdrh/reglistpage.html. Second, FDA does approve certain medical devices, namely the class III devices specified in section 515(a) of the Act (21 U.S.C. 360e(a)). Please correct these misstatements on your website and in your other promotional materials.
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 (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.
Charles M. Breen