- E-Care Technology Corp.
- 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|
White Oak Building 66
Silver Spring, MD 20993
NOV 24, 2015
VIA UNITED PARCEL SERVICE
Mr. Kun-Yuan Ko
E-Care Technology Co.,Ltd.
8F-11, No. 35, Hsin-Tai Road
Dear Mr. Ko:
During an inspection of your firm located in Chubei City, Taiwan, on July 6, 2015, through July 9, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures clinical electronic thermometers. 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. These violations include, but are not limited to, the following:
1. Failure to 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 does not require verification of the effectiveness of corrective action, such that actions do not adversely affect finished devices. Additionally, your firm's CAPA procedure does not require specifying the data sources to be analyzed and the statistical methodology to be employed to analyze the CAPA data, to include production nonconformances. Further, your firm's CAPA procedure does not require investigation of the cause of the nonconformities related to product, processes, or other quality problems.
b. Three CAPAs reviewed during the inspection were completed without verification or validation that such corrective actions were effective and did not adversely affected the finished devices.
2. Failure to 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, your firm's procedures do not address evaluating complaints to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting (MDR).
3. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). Specifically, your firm's rework procedures do not require documentation of rework activities.
4. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c). For example, your firm's thermometer design history file does not include design inputs for the LCT300 and LCT600 thermometer models.
5. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm's nonconformance procedure requires the nonconforming product to be identified with a failure symbol code, indicating the type of nonconformance. However, when nonconforming thermometers were segregated for repair, the failure symbol code was not maintained. Thermometers were repaired without identification of the type of nonconformance.
6. 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 Part 820, as required by 21 CFR 820.184. For example:
a. Your firm has not established a DHR procedure.
b. Your firm's DHRs do not demonstrate that the device is manufactured in accordance with the DMR, to include the primary identification label and labeling used for each production unit.
7. Failure to maintain Device Master Records (DMRs), as required by 21 CFR 820.181. For example, your firm has not established a DMR for the thermometers, to include packaging and labeling.
8. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120. For example, your firm has not established labeling procedures to require labeling inspection for accuracy, DHR labeling release documentation, and labeling control in manufacturing to prevent mix ups.
Our inspection also revealed that your firm's clinical electronic thermometers 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 fumish 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 (MDR). Significant violations include, but are not limited to, the following:
9. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm's Post Market Surveillance and Alarm System Procedure, dated December 4, 2014, does not include requirements for Medical Device Reporting.
Given the serious nature of the violations of the Act, the clinical electronic thermometers 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 violations described in this letter. 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.
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 Ill 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 Compliance, Field Inspections Support Branch, White Oak Building 66, Room 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #482261 when replying. If you have any questions about the contents of this letter, please contact LT David Dar, Acting Chief, Foreign Enforcement 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 lnspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality managementsystems. 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
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