- Delivery Method:
- United Parcel Service
- Medical Devices
Recipient NameNeeraj Jha
- Unetixs Vascular, Inc.
125 Commerce Park Road
North Kingstown, RI 02852-8420
- Issuing Office:
- Office of Medical Device and Radiological Health Operations (Division 1)
CMS # 598016
February 4, 2020
Dear Mr. Jha:
The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Unetixs Vascular Inc., 125 Commerce Park Road, North Kingstown, RI, from September 17 through October 29, 2019. During the inspection, FDA investigators determined that your firm is a manufacturer of vascular diagnostic ultrasound systems, such as your MultiLab® Series of devices. 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.
Under separate cover, FDA’s Center for Devices and Radiological Health (CDRH) plans to contact you to gather additional information regarding the technological characteristics and intended use of the MultiLab Series ROODRA vascular diagnostic device. This information is needed in order to determine the appropriate regulatory pathway for this device.
This inspection revealed that the above 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We received your response dated November 19, 2019, from John Haefele, Vice President and General Manager. which responded to the Form FDA 483, List of Inspectional Observations issued to your firm on October 29, 2019. We address your response below.
Your significant violations are as follows:
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 C.F.R. § 820.30(a). The following design controls were inadequate during the development of the MultiLab® Series ROODRA (ROODRA), which has been distributed since September 28, 2018:
• Failure to establish a design and development plan, as required by 21 C.F.R. § 820.30(b).
• Failure to establish design inputs, as required by 21 C.F.R. § 820.30(c).
• Failure to establish design outputs, as required by 21 C.F.R. § 820.30(d).
• Failure to review your design, as required by 21 C.F.R. § 820.30(e).
• Failure to validate your design, as required by 21 C.F.R. § 820.30(f).
During the inspection, your firm indicated Unetixs has manufactured and distributed (b)(4) ROODRA vascular diagnostic devices since September of 2018. These devices have been distributed prior to establishing a Design History File (DHF) that complies with FDA’s design control requirements described above.
2. Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 C.F.R. § 820.70(a). For example, your firm has not established any approved procedures regarding the manufacture of the ROODRA at Unetixs, including any requirements to ensure these devices are tested to ensure they conform to required specifications, such as electrical leakage, acoustic output, electromagnetic-compatibility (EMC) and electrical safety.
We reviewed your firm’s response to the two items noted above and conclude that they are not adequate. We understand that you stopped shipping all ROODRA devices, opened CAPA’s 1437 and 1439, and initiated additional testing (electrical safety, Standard 60601, SW etc.). However, your response does not address how you will address these systemic deficiencies. In response to this Warning Letter, you should provide a summary of your CAPA findings to date and describe how you will prevent these failures from recurring.
3. Failure to establish and maintain procedures for acceptance activities that include inspections, tests, or other verification activities, as required by 21 C.F.R. § 820.80(a). For example, during the inspection, we reviewed two years of incoming inspection records for the Revo motherboards, part 12921-0000-01, a critical component of your vascular diagnostic devices. This review revealed that your firm accepted four lots of motherboards that failed voltage output during acceptance testing.
This is a repeat deficiency from our 2017 Warning Letter.
We reviewed your firm’s response and conclude that it is not adequate. In response to this Warning Letter, you should describe the actions you are taking to prevent this failure from recurring.
4. Failure to establish and maintain procedures for implementing corrective and preventive actions, as required by 21 C.F.R. § 820.100(a). A review of selected CAPA’s revealed the following:
• CAPA 1364 was opened on 03/29/2017 to address lack of procedures for acceptance of incoming product and was documented as being closed on 04/23/2019. During the current inspection, it was found that nonconforming motherboards have been accepted as approved materials, for use in the finished medical devices and distributed into stock and to customers.
• CAPA 1411 was opened on 07/27/2018 to address PVR (Pulse Volume Recording) waveform sensors failures within MultiLab ® Series II LHS. Your firm continues to receive complaints for this issue, including complaint U75145, dated May 6, 2019. This CAPA remained open during the inspection and did not yet describe any existing or potential cause of the nonconformance, nor did it identify any action needed to correct and prevent recurrence of this issue.
This is a repeat deficiency from our 2017 Warning Letter.
We reviewed your firm’s response and conclude that it is not adequate. You indicated you have opened a number of CAPAs to address the violations noted during the inspection and are in the process of implementing corrective actions. However, you have not provided sufficient detail to ensure your corrective actions will address these violations, including significant, continuing CAPA violations. In response to this Warning Letter, you should provide confirmation that your CAPA system is capable of collecting and analyzing information, identifying and investigating existing and potential product and quality problems, and taking appropriate, effective, and comprehensive corrective and preventive action to prevent the recurrence of problems.
5. Failure to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification, as required by 21 C.F.R. § 820.198(c). For example, during the inspection 9 out of 20 complaints reviewed revealed your firm failed to either investigate the possible failure of the device to meet its specifications or to document your justification for not investigating.
This is a repeat deficiency from our 2017 Warning Letter.
We reviewed your firm’s response and conclude that it is not adequate. You indicated that you opened CAPA 1446 to address continuing complaint failures. However, your response does not address how you will address this continuing, systemic deficiency. We are also concerned that your CAPA system is not robust enough to ensure the above CAPA will correct the underlying problems.
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. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been corrected. Also, should FDA determine that your devices do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted. More information on processes for persons denied a CFG can be found at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices. If you believe that your products are not in violation of the Act, please respond to FDA with your reasoning and any supporting information for our consideration.
We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment's manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your establishment has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
• Initial certifications by consultant and establishment – August 7, 2020
• Subsequent certifications – August 7, 2021 and August 7, 2022
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, 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 (which must address systemic problems) 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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
If you have questions regarding any issues in this letter, please contact Compliance Officer, Karen Archdeacon at 781-587-7491 or at email@example.com. Please send your reply electronically to Gina Brackett, Director of Compliance Branch, at firstname.lastname@example.org.
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.
Acting Program Division Director
Office of Medical Device and Radiological Health
Cc: Mr. Vinod Ramani, Chairman
Opto Circuits (India) Ltd.
#83 Electronics City, Bengaluru – 560 100, Karnataka, India