WARNING LETTER
Deymed Diagnostic s.r.o.
MARCS-CMS 671076 —
November 07, 2023
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Kamil Holub
Deymed Diagnostic s.r.o.
Kudrnacova 533
Hronov
54931
Nachod CZ
Czechia
info@deymed.com
Issuing Office:
"OHT5: Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality"
United States
Secondary Issuing Offices
United States
WARNING LETTER
CMS # 671076
CC: valsa@deymed.com
November 7, 2023
Dear Mr. Kamil Holub:
During an inspection of your firm Deymed Diagnostic s.r.o., located in Hronov, Nachod, Czech Republic on July 24, 2023, through July 27, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a variety of Class II, non-sterile, products: 1) BrainFeedback Pro and 2) TruScan LT. Your firm also contract manufactures the following Class II, non-sterile, product: 1) DuoMAG NL. 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 two responses from Mr. Kamil Holub, Chief Executive Officer (CEO) of Deymed Diagnostic s.r.o. dated August 17, 2023, and September 15, 2023, addressing 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 design control procedures to control the design of the device in order to ensure that specified requirements are met, as required by 21 CFR 820.30(a)
Specifically, your firm’s Design and Development Procedure, Document #
(b)(4)
, states that the purpose of this procedure is to describe control of product development from establishing of requirements on product till transfer to production and following product changes. However, your firm has yet to subject the Class II BrainFeedback PRO to the design control process. Your firm has been shipping these units to the United States (U.S.) since 2015.
We reviewed your firm’s responses dated August 17, 2023, and September 15, 2023, and concluded that your firm’s response is not adequate. In your responses, you submitted documentation of your corrective action plan and remediation progress to-date. We acknowledge that your firm opened “CAPA2023/04 BrainFeedback Pro USA Design Controls”, revised
(b)(4)
Design and Development Procedure so that it specifies design inputs and outputs and a design verification and validation plan, completed personnel training on the new procedures and processes and discontinued the sale of the BrainFeedback Pro in the U.S. In your response dated September 15, 2023, your firm indicates that there are several corrective actions in progress, including but not limited to the following: 1) Test the BrainFeedback Pro for electrical safety according to the latest revision of IEC 60601-1, 2) Make a gap analysis for remaining US devices (TruScan Neurofeedback and DuoMag NL), 3) Complete the Design History File (DHF) for BrainFeedback Pro, 4) Delete BrainFeedback Pro proprietary name in FDA Unified Registration and Listing Systems (FURLS) Database and 5) Delete Unique Device Identifier (UDI) 08592566001017 from the Global Unique Device Identification (GUDID) Database. However, as of October 31, 2023, it does not appear that your firm has deleted its entry in the GUDID Database, and it is not clear what your firm intends to do to ensure that BrainFeedback Pro devices that were previously sold in the US are in compliance with the Quality System Regulation. For this reason, your firm’s response is inadequate.
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, under Section 2.4.1 (page 2) of your firm’s Customer Complaints Procedure - Doc #
(b)(4)
, a complaint is defined as follows:
Complaint – …written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety, or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices, according to ISO 13485.
…any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution, according to FDA 21 CFR Part 820.
Your firm has received over 180 complaints from your United States customers since 2019 and none of the complaints have been evaluated to determine if the reported event is required to be submitted to the FDA as a Medical Device Report and if the incidences require a failure investigation. For example:
Complaints (2 total) from
(b)(4)
Customer Complaint #
Complaint Description
(b)(6)
sensitive CRPS patient had red mark on skin for a few days
(b)(6)
failure of liquid cooling unit
Complaints (184 total) from
(b)(4)
Customer Complaint #
Complaint Description
(b)(6)
CP23-017 I have been having problems getting my DeyMed to boot up…
(b)(6)
CP23-013 The client said that a patient felt a mild shock when using the system.
(b)(6)
CP22-020 It looks like the device is no longer working. It appears to be a little swollen. Possibly the battery I am assuming.
We reviewed your firm’s responses dated August 17, 2023, and September 15, 2023, and determined that the adequacy of your firm’s response cannot be determined at this time. We acknowledge that your firm opened “CAPA2023/04 Customer Complaints”, revised
(b)(4)
Customer Complaints (filename “
(b)(4)
”) and completed personnel training on the new procedures and processes, which includes revised procedures for complaint recording, evaluating, and reporting, including use of the Customer Complaint (CC) form by complaint handling unit members and the documentation of complaints on a complaint register. However, your firm has not completed a retrospective review of all complaints received from your U.S. customers since 2019 and a failure investigation (if required) per the revised procedure provided in your firm’s response. Being that your retrospective review for the cited nonconformance has not been completed, the adequacy of your firm’s response cannot be determined at this time. Please provide documentation of your retrospective review.
3. 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). Specifically, your firm has yet to establish procedures for the manufacturing of the various Printed Circuit Board Assembly (PCBA) for the TruScan LT, using the automated pick and place machines (
(b)(4)
and
(b)(4)
).
The TruScan LT Neurofeedback has a total of
(b)(6)
Printed Circuit Boards (PCBs) in each unit. However, your firm has yet to establish procedures or working instructions for the manufacturing of the various PCBs for the TruScan LT using the automated pick and place machines (
(b)(4)
and
(b)(4)
).
We reviewed your firm’s responses dated August 17, 2023, and September 15, 2023, and concluded that your firm’s responses are not adequate. We acknowledge that your firm opened “CAPA2023/05 PCB Manufacturing Process”, revised
(b)(4)
Document Controls (filename “
(b)(4)
”), revised the new printed circuit board work instruction (filename “
(b)(4)
”) and completed personnel training on the new procedures and processes. Your firm stated that it plans to complete the installation and qualification of the new automated pick and place machine and a retrospective review of the production processes for other devices (e.g., DuoMag NL and TruScan Neurofeedback Device). However, it is not clear how your firm intends to ensure that all devices in the US market were manufactured to ensure that the device conforms to its specifications. Therefore, your firm’s response is not adequate.
4. Failure to establish and maintain adequate procedures to ensure that device history records for each batch, lot or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record, as required by 21 CFR 820.184.
Specifically, during this inspection, eleven Device History Records (DHRs) from 2023 (pertaining to the TruScan LT) were selected for review. The following deficiencies were noted:
None of the DHRs included or referred to the location of the primary identification label and labeling used for each production unit; and
None of the DHRs included or referred to the location of the unique device identifiers (UDIs) used for each production unit.
We reviewed your firm’s responses dated August 17, 2023, and September 15, 2023, and concluded that your firm’s responses are not adequate. We acknowledge that your firm opened “CAPA2023/07 DHR to Include Labels and UDIs”, created a new form to record all used device labels into the DHR and revised
(b)(4)
Document Controls (filename “
(b)(4)
”) so that it clearly contains all required elements stated in 21 CFR 820.184 and completed personnel training on the new procedures and processes. However, your firm did not indicate that previous DHRs for US devices would be retrospectively reviewed and updated to ensure the required information is included. Therefore, your firm’s response is not adequate.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal 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 addressed.
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 address 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. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent via email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2, FDA Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 671076 when replying. If you have any questions about the contents of this letter, please contact: Amber Ballard, PhD at Amber.Ballard@fda.hhs.gov.
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 any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely yours,
/S/
CAPT Nina Mezu-Nwaba, PharmD, MPH, MSc
Deputy Director
OHT5: Office of Neurological and Physical
Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Robert V. Packard (U.S. Agent)
Medical Device Academy Inc.
Shrewsbury, VT US 05738
Email: Rob@13485cert.Com
Content current as of:
01/09/2024
Regulated Product(s)
Medical Devices