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WARNING LETTER

Mandelay Kft MARCS-CMS 603799 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Medical Devices

Recipient:
Recipient Name
Mr. Kornél Tókics
Recipient Title
Managing Director
Mandelay Kft

Pest
Gyartelep Hrsz 12001/33 Szigetszentmiklos
2310
Hungary

Issuing Office:
Center for Devices and Radiological Health

10903 New Hampshire Avenue
Silver Spring, MD 20993
United States


February 3, 2020

WARNING LETTER

Dear Mr. Kornél Tókics:

During an inspection of your firm located in Tokol, Pest, 2316 Hungary on October 14, 2019 through October 17, 2019, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Scientific Consciousness Interface Operation (SCIO) System and the Quantum University Energetic System Technology 9 (Quest 9) 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 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 requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received responses from your firm on November 6, 2019, November 16, 2019, and January 14, 2020 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 the responses 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 adequate 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.

For example, design control procedures noted in Quality Manual Section 8.3 have not been adequately implemented for the development of the Quest 9 device:

a) Your firm provided a copy of Software Beta Test Summary Report (dated May 2, 2018) as the design validation for the Quest 9 device. However, your test report does not demonstrate that a full design validation was performed to include the execution of the device functions in a real or simulated environment to demonstrate that your devices conform to defined user need and intended uses. Additionally, Software Beta Test Summary Report indicated that defects were found and corrected, but it does not provide a description of the defects found, the corrections made, and if a re-test was performed.

b) Your firm maintains engineering drawings and manufacturing procedures that describe various hardware outputs. However, design verification of these hardware requirements was not documented in the DHF.

c) Software problems documented on Software Failure Analysis/Corrective Action Report indicate that corrections were made to the software. However, your firm’s software verification test, Test Cases for Clasp 64 (dated March 19, 2019), does not specify which test cases are related to the software corrections. Moreover, these changes were not verified prior to implementation.

Your firm’s responses did not address Observation 1 of the FDA 483.

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

Specifically, Quality Manual (b)(4) states that your Quality Manager receives complaints and completes the RGA/Complaint Form. However, software related complaints (i.e., reports of issues related to inability to activate software after download, error messages, inability to access data or programs, etc.) are handled via telephone and not documented or investigated per Quality Manual (b)(4).

Your firm’s responses did not address Observation 2 of the FDA 483.

3. Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a)(1).

For example, Section 2 of Assembly Procedure of the Devices requires the use of an electrostatic discharge (ESD) wrist strap and ESD gloves when working with device panels. However, your firm’s procedures for protection of ESD do not include periodic Inspection and test of ESD grounds and routine checks of the wrist straps to ensure these are inspected for adequacy and proper functioning and that these activities are documented and reviewed.

Your firm’s responses received November 6, 2019, November 16, 2019 and January 14, 2020, are not adequate. Your firm sent documents that do not address corrective actions, retrospective review and/or a review of other processes to ensure proper verification and documentation is performed. Although your firm provided back-dated training records, it is not clear if your training has been done since your training document is not signed.

4. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120(b).

For example, your examination for accuracy and release for use of the labels, including the date and signature of the individual(s) performing the examination, is not documented in your Device History Record (DHR). Additionally, your SCIO devices do not include the primary identification label and labeling use.

Your firm’s responses did not address Observation 4 of the FDA 483.

Given the serious nature of the violations of the Act, the Scientific Consciousness Interface Operation (SCIO) System and the Quantum University Energetic System Technology 9 (Quest 9) devices manufactured 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 violation(s) described in this letter. We will notify you regarding the adequacy of your firm’s response(s) and the 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.

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 (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. 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 Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, Rm 3657, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number (CMS case # 603799) when replying. If you have any questions about the contents of this letter, please contact: Heather Dean, PhD at 240-402-9874.

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/

Carlos Peña, Ph.D., M.S.
Director
OHT5: Office of Neurological
   and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
Jerry Doane
Pragmatic Compliance LLC
15815 SW 11th Court Road
Ocala, FL 34473