- Cardionics SA
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
OCT 16, 2015
VIA UNITED PARCEL SERVICE
Rue Gabrielle Petit 4/2
Dear Mr. Graux:
During an inspection of your firm located in Brussels, Belgium on July 27, 2015, through July 29, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the CarTouch Portable ECG Electrocardiograph Device. 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 a response from Gert Fauconnier, dated August 10, 2015, 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. Your firm’s response, dated September 10, 2015, to the FDA 483 was not received within fifteen business days of issuance of the FDA 483. The response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example:
a. Your firm’s CAPA procedure, “(b)(4),” dated March 14, 2011, does not address the following:
i. Analysis of sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
ii. Employing appropriate statistical methodology where necessary to detect recurring quality problems; and
iii. Verification or validation of the corrective and preventive action to ensure that such action does not adversely affect the finished device.
b. Your firm did not verify or validate 11 CAPAs initiated since 2013 for effectiveness.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include a retrospective review of design files, to ensure that CAPAs were verified, or validated where appropriate, to ensure that such action does not adversely affect the finished device.
2. Failure to adequately 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; complaint handling procedure, “(b)(4),” dated March 14, 2011, does not ensure that:
a. Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting;
b. MDR reportable events are maintained in a separate portion of the complaint files or otherwise clearly identified; and
c. Complaint investigation records include the following:
i. The name of the device;
ii. The date the complaint was received;
iii. Any device identification and control number;
iv. The name, address, and phone number of the complainant;
v. The dates and results of the investigation; and
vi. Any reply to the complainant.
We reviewed your firm’s response and conclude that it is not adequate. The response did not include a plan to ensure past complaints are adequately evaluated and maintained in accordance with the new procedure. In addition, the response did not include a plan to train personnel to execute the new complaint handling procedure.
3. Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, design validation procedure, “(b)(4),” dated July 15, 2015, does not ensure that:
a. Design validations are performed under defined operating conditions on initial production units, lots, or batches, or their equivalents;
b. Design validations need to include testing of production units under actual or simulated use conditions; and
c. Results of the design validation, including identification of the design, methods, the date, and that the individuals performing the validation, are documented in the Design History File (DHF).
We reviewed your firm’s response and conclude that it is not adequate. The response did not include a retrospective review of design files, to ensure that the design of the devices manufactured is adequately controlled.
4. Failure to maintain device master records (DMRs), as required by 21 CFR 820.181. For example, DMRs for the CarTouch ECG do not include, or refer to the location of, the following:
a. Device specifications, including appropriate drawings, component specification, and software specification;
b. Production process specifications including the appropriate equipment specification, production methods, production procedures, and production environment specification;
c. Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment used;
d. Packaging and labeling specifications; and
e. Installation, maintenance, and servicing procedures and methods.
We reviewed your firm’s response and conclude that it is not adequate. The response did not indicate when training will be conducted for the DMR work instruction. In addition, the response did not include a retrospective evaluation to ensure the lack of a DMR did not result in the release of nonconforming products.
5. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, DHRs do not include the primary identification label used for each production unit. In addition, DHRs for the CarTouch ECG do not contain identification information of test equipment used for the finished device acceptance.
We reviewed your firm’s response and conclude that it is not adequate. The response did not include documentation that personnel have been trained to execute the new procedure.
Our inspection also revealed that the CarTouch Portable ECG Electrocardiograph Device is 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 regarding the device that is required by or under Section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant deviations include, but are not limited to:
6. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm does not have an MDR procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s new MDR Procedure, titled “(b)(4),” dated August 28, 2015, does not address the following:
a. Internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event” and “serious injury,” and the definition for the term “reasonably suggests” found in 21 CFR 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. Internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
i. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
ii. The procedure, as written does not specify who makes the decision for reporting events to the FDA.
iii. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
c. Internal systems that provide for timely transmission of complete medical device reports to the FDA. For example, the circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports.
Additionally, the procedure includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure.
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 action (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. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.
Refer to CMS case #478690 when replying.If you have any questions about the contents of this letter, please contact LT David Dar, Acting Chief, Foreign Enforcement Branch, at email@example.com (email) or +1(240)402-4020 (telephone).
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.
CAPT Sean M. Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health
JWM Associates, LLC.
15-2807 Puna Parkway
Pahoa, Hawaii 96778