Source: https://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm458915
Timestamp: 2019-02-15 19:37:28
Document Index: 20193545

Matched Legal Cases: ['§ 321', '§ 352', '§ 360', 'art 803', '§ 351', 'art 820']

Reka Health Pte Ltd 12/19/14
Reka Health Pte Ltd.
No 2 International Business Park
#11-01/02 Tower One, The Strategy
Dear Mr. Tan Kae Yuan:
During an inspection of your firm located in Singapore on August 18, 2014, through August 21, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Reka E100 cardiac rhythm monitor. 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.
Our inspection revealed that your firm's Reka E100 cardiac rhythm monitors are 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 respecting 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.
We received a response from you dated September 12, 2014, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional 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 develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, your firm did not develop, maintain. and implement a written MDR procedure that includes the following:
a. Requirements for the timely and effective identification, communication, and evaluations of events that may be subject to MDR requirements;
b. A standardized review process or procedure for determining when an event meets the criteria for reporting;
c. A requirement for timely transmission of complete medical device reports; and
d. Documentation and record keeping requirements for:
i. information that was evaluated to determine if an event was reportable, and
ii. systems that ensure access to information that facilitates the timely follow-up and inspection by FDA.
Your firm's response did not address this violation.
This inspection also 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. Significant violations include, but are not limited to, the following:
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 (CAPA) procedure, (b)(4):
a. Does not appear to include the requirement for analyzing sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
b. Does not require appropriate statistical methodology to be employed where necessary to detect recurring quality problems; and
c. Does not include requirements for verifying or validating the corrective and preventive action to ensure that such action does not adversely affect the finished device.
We reviewed your firm's response and conclude that it is not adequate. Your firm provided (b)(4) and an updated version of (b)(4). These documents include requirements to ensure that the actions do not adversely affect the finished device. A section was also added to the CAPA Form which requires verification for whether the actions adversely affect the finished device. However, your firm did not correct the deficiencies found in the CAPAs examined during the inspection. Additionally, your firm did not ensure that closed CAPAs comply with your firm's updated procedures. Finally, your firm did not perform personnel training on the new procedures.
3. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your firm's design control procedures:
a. Do not require design validation to be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents;
b. Do not require testing of production units under actual or simulated use conditions; and
c. Do not require the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, to be documented in the design history file (DHF).
We reviewed your firm's response and conclude that it is not adequate. Your firm updated its procedure (b)(4), "Product Development Process," which now includes requirements for the listed deficiencies to be performed on preproduction samples. Your firm stated that it would challenge on-going projects against the updated procedure by October 31, 2014. However, your firm did not establish procedures for design review or conduct personnel training on the new procedures.
4. Failure establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, as required by 21 CFR 820.30(e). For example, your firm's design control procedures do not ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed.
The adequacy of your firm's response cannot be determined at this time. Your firm updated its design control procedures, which now include requirements to ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. Your firm stated that it would challenge on-going projects against the updated procedure by October 31, 2014. However, your firm did not specify whether it plans on performing personnel training on the procedure to be generated.
5. Failure to maintain device history records (DHR's), as required by 21 CFR 820.184(e). For example, the DHR for "Delivery Order for (b)(4)," does not include, or refer to the location of, the primary identification label and labeling used.
The adequacy of your firm's response cannot be determined at this time. Your firm is in the process of establishing a procedure to provide clarity on DHR requirements, which will also cover DHR requirements for its sub-contractors. The completion date for the procedure is set for October 31, 2014. However, your firm did not specify whether it plans on performing personnel training on the procedure to be generated.
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 Compliance, Field Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #4401 04 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at telephone +1 (301) 796-5587 or fax +1 (301) 847-8139.