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U.S. Department of Health and Human Services

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Enforcement Actions

Rubimed AG 5/6/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

 

May 6, 2013
WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Joseph Huber
President and CEO
Rubimed AG
Grossmatt 3
Hergiswil,
Switzerland CH-6052
 
Dear Mr. Huber:
 
During an inspection of your firm located in Hergiswil, Switzerland, on January 28, 2013, through January 29, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the REBA biofeedback device.  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 to affect the structure or function of the body.
 
This inspection revealed that this device is 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, its manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from your firm dated February 4, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. 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 to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
 
For example, Rubimed AG owns the trademark for the REBA Class II biofeedback medical device; however there were no design control procedures available at your firm.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it will create a design control process to trace design changes. The response stated that all persons would be trained. Your firm has not yet completed or provided your design control procedure to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your response to this observation. 

2.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

For example, your firm’s corrective and preventive action procedures in Chapter 8.5.2, Corrective Action and 8.5.3, Preventive Action of the Management Handbuch, Document 0I, Revision 1.0 (German version dated March 23, 2009, and its English translation version 2.0, dated January 7, 2013) do not include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems. Your firm’s corrective and preventive action procedures do not include requirements for verifying or validating corrective and preventive actions to ensure that such actions are effective and do not adversely affect the finished device.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it has revised its process and that it will train its personnel. Your firm has not provided revised corrective and preventive action procedures to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your response to this observation.
 
3.    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). 
 
For example, your firm’s complaint handling procedures Monitoring and Reporting System Document AA 07, Revision 1.0, dated March 23, 2009, does not include requirements to ensure that all oral complaints are documented upon receipt, that complaints are handled in a uniform and timely manner, and that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it has revised its process and that it will train its personal. Your firm has not provided revised complaint procedures or complaint forms to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your firm’s response to this observation.
 
4.    Failure to review and evaluate all complaints to determine whether an investigation is necessary and to maintain a record when no investigation is made that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).
 
For example, your firm’s complaints procedures and associated forms (Form 05, Compilation of Complaints and Form FO 02, Recall Medical Devices and Pharmaceuticals Form) do not include requirements to ensure that, for complaints where no investigation was made, there is documentation of the reason why no investigation was made and documentation of the name of the individual responsible who made that decision.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it has revised its process and that it will train its personnel. Your firm has not provided revised complaint procedures or complaint forms to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your firm’s response to this observation.
 
5.    Failure to maintain a records of investigation by the formally designated unit, as required by 21 CFR 820.198(e).
 
For example, your firm’s complaint handling procedures do not include requirements which state that the record of the investigation, when made, shall include the dates and results of investigations and any replies to the complainants.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it has revised its process and that it will train its personnel. Your firm has not provided revised complaint procedures or complaint forms to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your firm’s response to this observation.
 
6.    Failure to define the type and extent of control to be exercised over product, services, suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(2). 
 
For example, your firm’s supplier monitoring procedures in Chapter 7.4.6, “Evaluating performance suppliers” in the Management Handbuch, Document 01, Revision 1.0 (German version dated March 23, 2009, and its English translation version 2.0, dated January 7, 2013), do not define the type and extent of control over suppliers.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it has revised its process and that it will train its personnel. Your firm has not provided revised purchasing control procedures to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your firm’s response to this observation.
 
7.    Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).
 
For example, your firm was unable to provide the investigator with any production procedures or work instructions.
 
8.    Failure to maintain records required at the manufacturing establishment or other location that are reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections, as required by 21 CFR 820.180. 
 
For example, your firm was unable to obtain design documents, production procedures/work instructions, production nonconformance records, design history file records, or design history records from your contract manufacturer, (b)(4)
 
9.    Failure to maintain device history records (DHRs), as required by 21 CFR 820.184. 
 
For example, your firm was unable to provide the investigator with any DHRs for previously manufactured devices.
 
10.    Failure to establish procedures for quality audits to be conducted by individuals who do not have direct responsibility for the matters being audited, as required by 21 CFR 820.22. 
 
For example, your firm’s quality audit procedures Chapter 8.2.2, “Internal Audit” in the Management Handbuch, Document 01, Revision 1.0 (German version dated March 23, 2009, and its English translation version 2.0 dated January 7, 2013), and work instructions, Interne Audit Work Instructions, AA 09, Revision 1.0, do not include requirements that ensure that individuals who conduct quality audits do not have direct responsibility for the matters being audited.
 
The adequacy of the response dated February 4, 2013, cannot be determined at this time. Your firm stated that it has revised its process and that it will train its personnel. You have not provided revised quality audit procedures to FDA. Additionally, your firm has not yet provided FDA with records of training. Without seeing evidence of implementation, and the documents listed above, FDA cannot determine the adequacy of your firm’s response to this observation.
 
Our inspection also revealed that your REBA biofeedback device is misbranded under section 502(t)(2) of the Act, 21 USC § 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC § 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
 
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. The procedure titled “AA – 07 Monitoring and reporting system / recall,”dated March 23, 2009, describes a process for recalls and reportability of events to other regulatory or competent authorities and not FDA. The referenced procedure is not an MDR procedure.
 
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
 
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
 
Our inspection also revealed that the REBA biofeedback device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Specifically, the REBA biofeedback device does not fall into the category of biofeedback devices that are exempt from premarket notification under CFR 21 882.505. Biofeedback devices are exempt when they are prescription battery powered devices that are indicated for relaxation training and muscle reeducation and prescription use. The REBA biofeedback device is not indicated for relaxation training and muscle reeducation. Additionally, the REBA biofeedback device is not battery powered and requires a 230V power supply with a voltage converter for proper operation. Therefore, both the stated claims and the safety of this device require evaluation in a marketing submission.
 
Given the serious nature of the violations of the Act, the REBA biofeedback devicesmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
 
Also, U.S. 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. 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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including 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 fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review.
 
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.  Refer to CMS case #393813 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585or via facsimile (301) 847-8128.
 
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. 
 
 
Sincerely yours,
/S/                                                                                   
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
    Radiological Health