- COTRONIC Technology Limited
- 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
DEC 1, 2015
VIA UNITED PARCEL SERVICE
Kwong Ping Wong
Cotronic Te chnology Limited
Room 1407,Worldwide Industrial Centre
43 Shan Mei Street
PEOPLE'S REPUBLIC OF CHINA
During an inspection of your firm located in Shenzhen, China, on July 13, 2015, through July 16, 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.
We received a response from Ms. Wai Ha Mok, General Manager, dated July 24, 2015, 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. Faiiure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a). For example, your firm has not validated the (b)(4) Clinical Electronic Thermometer, Model TM21.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response included Operational Qualification data for (b)(4) and training records. However, your firm's response did not include documentation of installation qualification (IQ) and performance qualification (PQ) for the (b)(4). Also, your firm's response did not include a retrospective analysis of other processes that may need to be validated.
2. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm's "Quality Policy and Objective Procedure," Document No. (b)(4), Version 1, states that each department shall present quality objectives on a monthly report and take action if the objective has not been achieved. However, when target limits were exceeded, your firm did not initiate CAPAs for the failure to meet the following quality objectives from 2013 to 2015:
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states your firm determined the cause of exceeded target limits. Also, your firm's response states your firm made corrections in production process management, work instructions, material management controls, and (b)(4) packaging, and provided training. However, your firm's response states that only issues noted in 2015 were addressed. Your firm's response does not state whether these corrections are applicable to issues identified in the 2013 and 2014 quality data analyses.
3. Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example, in the manufacturing of the Clinical Electronic Thermometer, Model No. TM02, the following equipment is not identified/approved and maintained/calibrated:
We reviewed your firm's response and conclude that it is not adequate. Your firm's response included an equipment list identifying the (b)(4) documentation. However, your firm's response did not include documentation in reference to (b)(4). Also, your firm's response did not include documentation of an analysis of other inspection, measuring, and test equipment to ensure that all equipment has been properly identified, calibrated, inspected, checked, and maintained.
4. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, the "Supplier Control Procedure," Document No. (b)(4), Version 1, does not require your firm to evaluate and select potential suppliers, contractors, and consultants, on the basis of their ability to meet specified requirements, including quality requirements. Specifically, your firm has not established specified requirements for approved suppliers (b)(4).
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states your firm has revised the "Supplier Control Procedure," Document No. (b)(4), Version 1, to include specific ISO or QMS certification. Your firm's response states your firm has provided training on the revised procedure, and included certificates for some of your firm's suppliers. However, there is no documentation that your firm has evaluated all of its suppliers of materials or components for medical devices.
5. 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 Clinical Electronic Thermometer, Model TM21.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response included a DMR for the Clinical Electronic Thermometer, Model TM21. However, your firm's response did not include documentation demonstrating that an analysis was conducted to ensure all of the medical devices your firm markets have DMRs. Your firm's response did not include an analysis of its records to determine if the lack of any DMRs resulted in nonconformances or other quality problems.
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 willnot 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 implementationof 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 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.
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 #481155 when replying. If you have any questions about the contents of this letter, please contact: Shumaya Ali, 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 lnspectional 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 investigateand 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
Cotronic Technology Limited
Block 7, West of ZhouShi Road
Xing Xiang Street, Bao An Zone
PEOPLE'S REPUBLIC OF CHINA
Charles Mack U.S.Agent IRC USA
12226 Washington Lane
Parker, Arizona 85344
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