Inspections, Compliance, Enforcement, and Criminal Investigations
Teamedics (Taishan) Manufacturing Co., Ltd 30-Jan-08
Department of Health and Human Services
Public Health Service
Center for Devices and
JAN 31 2008
VIA FEDFRAL EXPRESS
Teamedics (Taishan) Manufacturing Co., Ltd.
Hang Cheng Industrial Area
Qian Jing Lu
Xi Xiang Town
Dear Mr. Wong:
During an inspection of your firm located in Shezhen, China on September 3, 2007, through September 6, 2007, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures heating pads. 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 are intended 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following.
1. Failure to validate those processes that cannot be fully verified with a high degree of assurance according to established procedures and failure to establish and maintain procedures for monitoring and control of validated processes, as required by 21 CFR 820.75, Process validation. For example, your firm did not perform process validation for the semi-automated PVC welders used to weld the edges of the heating pads, Your firm did not perform process validation on the semi-automated PVC electrical cord welders. Your firm was unable to produce a written procedure to indicate you had established monitoring and control of these processes.
2. Failure to establish and maintain written corrective and preventive action (CAPA) procedures, as required by 21 CFR 820.100. For example, your firm's general manager representative acknowledged that the firm has not established a CAPA procedure with HoMedics for your device.
3. Failure to establish and maintain a design history file for each type of device, as required by 21 CFR 820.30(j). Design history file. For example, your firm stated you maintain documents for two years after which time the documents, including the design file, are thrown away. The investigator was unable to review any design documentation including design changes. Your firm stated that the last design change was more than [(b)(4)] ago.
4. Failure to document instructions, standard operating procedures, and methods that define and control the manner of production of the medical device, as required by 21 CFR 820.70(a). General production and process controls. For example:
a. There are no written work instructions detailing how to perform soldering on the control box printed circuit boards for the heating pads. Your firm stated that there were no manufacturing instructions identifying how to complete the soldering. Your firm indicated that you use an electrical industry standard for the soldering but you were unable to produce the electrical standard to confirm the statement.
b. Your firm uses a [(b)(4)] to test the off, low, medium, and high heating levels of the heating pad. Your firm has not validated the [(b)(4)] for its intended use.
5. Failure to establish and maintain written procedures for acceptance activities including inspections, test, or other verification activities, as required by 21 CFR 820.80(a), General receiving, in-process, and finished device acceptance. For example:
a. Your firm uses a [(b)(4)] to test the off, low, medium, and high heating levels of the heating pad. There are no written procedures for how co use the [(b)(4)] for testing heating pads.
b. The heating pad final inspection is completed by [(b)(4)] A final inspection report was reviewed and heating pads were signed off for release by Teamedics' quality assurance department when the heating pads did not meet temperature specification requirements.
6. Failure to establish and maintain written procedures to adequately control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c), Environmental control. For example, during the inspection, management stated to the investigator that your firm never made a complete assessment of what was needed in terms of environmental controls (e.g., electric static discharge monitoring) and so never determined how to implement or monitor environmental control issues.
7. Failure to ensure that all inspection, measuring, and test equipment is suitable for its intended purpose and capable of producing valid results, as required by 21 CFR 820.72(a}, Control of inspection, measuring, and test equipment. For example:
a. Your firm uses a [(b)(4)] to keep electricity within, acceptable voltage limits at the printed circuit board station to avoid power surges that could be detrimental to device quality. The unit was not calibrated or verified to be effective for its intended use. Your firm was unable to produce written procedures or a user manual for the voltage regulator.
b. Your firm uses a [(b)(4)] for testing printed circuit boards. The unit was not calibrated or verified to be effective for its intended use. Your firm was unable to produce written procedures or a user manual for the capacitance meter. The general manager stated to the investigator that the capacitance meter had never been calibrated.
c. The PVC welders used to manufacture heating pads contain [(b)(4)] that, according to the general manager, specify an operational pressure range in order to function. Your firm does not calibrate these [(b)(4)] Your firm does not have written procedures, a user manual or written operational specifications in order to ensure that the air supply is adequate.
8. Failure to establish and maintain adequate procedures to control or dispose of product that does not conform to specified requirements, as required by 21 CFR 820.90, Nonconforming product. For example, your firm had twenty-six separate non-conformances in their September 2006 lot production of heating pads and did not document the final disposition of these device. Your firm indicated that you do not document the disposition of non-conformances.
9. Failure to adequately maintain device history records, as required by 21 CFR 820.184, Device history record. For example, your firm did not document operating parameters and processing specifications for heating pads in a device history file for the PVC welders used in heating pad manufacturing.
10. Failure to retain records for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution, as required by 21 CFR 820.180(b). Record retention period. For example, your firm stated that you maintain documents for two years which time the documents, including the design file, are thrown away. The expected life of the heating pads is more than two years.
11. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 820.50(b), Purchasing data. For example:
a. There is no written agreement and procedure between HoMedics Michigan, HoMedics China, and Teamedics prescribing the specifications and sampling for the finished device testing and acceptance testing and no procedure prescribing the necessary acceptance records required by the regulation for these activities. Further, there is no agreement and procedure between the three parties to ensure the review and approval of all activities required in the Device Master Record and to ensure that the Device History Record demonstrates the device was manufactured in accordance with the Device Master Record.
b. There is no written agreement and procedure between HoMedics Michigan, HoMedics China, and Teamedics indicating who has authority for lot release and distribution and how the release is to be implemented and controlled. The HoMedics China QA Manager stated to the investigator that the current agreement between HoMedics China and Teamedics has not been formalized.
c. There is no written agreement and procedure between HoMedics Michigan, HoMedics China, and Teamedics established to document, exchange, and coordinate the handling, investigating and analyzing of nonconforming data, complaints, and corrective and preventive actions.
Given the serious nature of the violations of the Act, all medical devices 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 may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
Also, U.S. federal agencies are advised of the issuance of all 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, Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to: William MacFarland, 2094 Gaither Road, Rockville, MD 20850, USA. If you have any questions about the content of this letter please contact: Amy Skrzypchak at (240) 276-0274 or (240) 276-0129.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable law, and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance system. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and
cc: HoMedics Inc,
3000 N. Pontiac Trail
Commerce Township, Michigan 48390-2720