- Nemschoff Chairs, Inc.
- Issuing Office:
- Minneapolis District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100 FAX: (612) 334-4142
November 7, 2014
Via UPS Overnight Delivery
Refer to MIN 15–01
C. Kent Gawart
Chief Operating Officer, Nemschoff Chairs
Herman Miller Healthcare, Inc.
855 E. Main Avenue
Zeeland, Michigan 49464
Dear Mr. Gawart:
During an inspection of your firm located at 909 N. Eighth Street, Sheboygan, Wisconsin, from June 30 through July 25, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures patient treatment chairs. 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 to affect the structure or any function of the body.
Our inspection also revealed that your firm’s Serenity treatment chairs are misbranded under section 502(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 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:
Failure to report to FDA in writing a correction or removal, conducted to reduce a risk to health posed by a device, as required by 21 CFR 806.10(a).
Specifically, from November 29, 2011, through June 3, 2014, your firm performed six (6) corrections in the field on the integrated heating element or other components that comprise your Serenity treatment chairs. The corrections have been performed via heat service kits being installed “on demand” to address heating element malfunctions, such as overheating, which causes burns on the chair and/or patient, or other heating element complaints that have been reported by multiple complainants since 2011.
We have reviewed your response dated August 15, 2014. We acknowledge your commitment to perform a retrospective review of all engineering change notices and service notices to determine if there are other reportable field corrections; you will notify the Agency accordingly. However, your response is inadequate in that you have not addressed how you will avoid this failure to notify the Agency of a field correction to reduce a risk to health in the future. You have not provided your updated procedure for Recalls, Corrections and Removals (SOP 10-40-05).
Your firm 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 civil money penalties. Also, federal agencies may be advised of the issuance of 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 15 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to Melissa I. Michurski, Compliance Officer, at the address on the letterhead. If you have any questions about the content of this letter please contact Ms. Michurski at (612) 758-7185.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Michael Dutcher, DVM
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