Inspections, Compliance, Enforcement, and Criminal Investigations
Don Tray Industries, Ltd 10-Apr-08
Department of Health and Human Services
Public Health Service
Minneapolis District Office
April 10, 2008
RETURN RECEIPT REQUESTED
Refer to MIN 08 - 11
Jeffrey P. Arndt
CEO and President
Don Tay Industries, Ltd.
2383 S. 162nd Street
New Berlin, Wisconsin 53151-2803
Dear Mr. Arndt:
During an inspection of your firm located in New Berlin, Wisconsin, on February 19-21, 2008, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrocardiography (ECG) electrodes. 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.
This inspection 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. Failure to maintain a design history file, as required by 21 CFR 820.30(j), to demonstrate that the design was developed following an approved design plan and the design control requirements of 21 CFR 820. Specifically, there are no documented design inputs [21 CFR 820.30(c)], outputs [21 CFR 820.30(d)], verification [21 CFR 820.30(f)], validation or risk analysis [21 CFR 820.30(g)] for the Softy Trode series of ECG electrodes. There was also no documentation to show that the design changes were verified and validated before implementation as required by 21 CFR 820.30(i).
2. Failure to have a device master record that includes or refers to the location of all production and process specifications as required by 21 CFR 820.181. For example, the device master record for the Softy Trode series of ECG electrodes does not contain specifications for the non-woven fabric component, reference to any testing or acceptance activities, or master copies of labeling.
3. Failure to maintain a device history record that demonstrates the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184. For example, you are not following the established procedures in the Batch Number Accounting Procedure, which requires the completion of a Production Machine Log Sheet for each batch of the Softy Trode series of ECG electrodes. Records are not being maintained to demonstrate that each batch of electrodes is manufactured in accordance with specified requirements.
4. Failure to establish complete quality system procedures in accordance with 21 CFR 820.20(e). For example, your firm has not defined, documented, and implemented quality system procedures for design control (21 CFR 820.30], complaint handling [21 CFR 820.198], medical device reporting [21 CFR 803], maintenance of the device master record [21 CFR 820.181], and acceptance activities [21 CFR 820.80].
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 FDA 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 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 Denise L. Burosh, Acting Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Ms. Burosh at (414) 771-7167 ext. 21.
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.
W. Charles Becoat