- Dongguan Jianwei Electronics Products Co., Ltd.
- 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
NOV 5, 2015
VIA UNITED PARCEL SERVICE
Jack Sentsun Huang
Vice President Electronic Products Division
Dongguan Jianwei Electronics Products Co. Ltd.
406 Qing Feng Road
Jin-Qiao Industrial Area, Qing-Xi Town
523653 Dongguan City
Dear Mr. Huang:
During an inspection of your firm located in Dongguan City, China, on June 29, 2015, through July 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures infrared ear thermometers, digital thermometers, and rectal 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 Eric Huang, General Manager, dated August 2, 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. Failure to adequately ensure that when 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, the automated (b)(4), used for manufacturing (b)(4), was not validated prior to use in production.
We reviewed your firm's response and conclude that it is not adequate. While your firm's response indicates that the procedure will be revised, the response did not include documentation demonstrating the process validation activities for (b)(4). Please provide documentation that your firm assessed other manufacturing processes to determine if you adequately conducted process validation, and performed remediation where necessary. Additionally, the response did not include rationale for statistical techniques and test methods used.
2. Failure to establish and maintain adequate procedures for the identification, documentation, validation or appropriate verification, review, and approval of design changes prior to their implementation, as required by 21 CFR 820.30(i). Specifically, the design change procedure, Design Change Management Procedure, (b)(4), does not include criteria for validation or verification for design changes.
We reviewed your firm's response and conclude that it is not adequate. While your firm's response indicates the procedure will be revised, the response did not include a plan to ensure past design changes were properly verified or validated. Additionally, the response did not include the revised procedure or a plan to train personnel to execute the revised procedure.
3. Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, the software used in the (b)(4) and the (b)(4) was not validated.
We reviewed your firm's response and conclude that it is not adequate. While your firm's response indicates that the procedure will be revised, the response did not include documentation of software validation for (b)(4). Additionally, the response did not include rationale for statistical techniques and the test methods used in validation (b)(4).
4. Failure to adequately establish and maintain procedures to control all documents that are required by 21 CFR Part 820, as required per 21 CFR 820.40. For example, multiple procedures were revised without monitoring and control by the Document Manager to ensure that the most current revision status is identified and reviewed for adequacy. The master list of procedures did not include additional changes not documented at the time of revision.
The adequacy of your firm's response cannot be determined at this time. While your firm's response indicates that the document control procedure will be revised, the response did not include documentation, namely the revised procedure.
Given the serious nature of the violations of the Act, infrared ear thermometers, digital thermometers, and rectal 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 violation(s) described in this letter. 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.
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 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 #481673 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 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 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
ROC Chinese-European Industrial Research Society
2064 Tamarin Drive
Columbus, Ohio 43235