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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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GRANTECH CO., LTD. 2/15/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

 

WARNING LETTER
 
FEB 15, 2012
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Chuck Li
President
Valeo Corporation, Taiwan
4F-3, No. 161 Sung-Teh Road
Taipei, Taiwan 110
 
Dear Mr. Li:
 
During an inspection of your firm, Grantech Co., LTD., located in Baoan District, Shenzhen, China, on October 15 through October 18, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures digital and infrared 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 an undated response on November 2, 2012, from Crystal Yu, Sales Specialist at Valeo Corporation, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We will address this response below, in relation to each of the noted violations. However, your firm’s responses dated December 27, 2012, and January 20, 2013, to the FDA 483, were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. The December 27, 2012, and January 20, 2013, responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.  These violations include, but are not limited to, the following:
 
1.    Failure to establish and maintain procedures for validating the device design. The results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, shall be documented in the Design History File (DHF), as required by 21 CFR 820.30(g). For example:

A.   Mr. C.C. Jean, your firm’s General Manager, stated that all of your firm’s design control procedures, with the exception of the procedures for design change and design drawing, are located in the procedure “Design Development Control Procedures” (MDDQP-033, Rev.A, dated September 25, 2002).  However, MDDQP-033 does not contain information that establishes the process your firm will follow to perform design validation.

B.   Your firm’s design validation documentation for the VT-601 infrared thermometer design project approved on October 20, 2010, lacks the following information:
 
1.    The dates the validation tests were conducted.
2.    The lots and batch numbers of the units used during validation.
3.    The ambient temperature ranges under which the testing was performed.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
2.    Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example:
 
A.   Mr. C.C. Jean, your firm’s General Manager, stated that all of your firm’s design control procedures, with the exception of the procedures for design change and design drawing, are located in the procedure “Design Development Control Procedures” (MDDQP-033, Rev.A, dated September 25, 2002). However, MDDQP-033 does not contain information that establishes the process your firm will follow to perform design transfer.
 
B.   Per your firm’s “Notice to Transfer to Production,” dated December 15, 2009, for Design Project VT-601, the infrared thermometer was transferred from design to production. However, the transfer of VT-601 from design to production occurred prior to the approval of the product’s design validation (approved October 20, 2010) and design verification (approved September 5, 2011).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
3.    Failure to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification, shall be documented in the DHF, as required by 21 CFR 820.30(f). For example:
 
A.   Mr. C.C. Jean, your firm’s General Manager, stated that all of your firm’s design control procedures, with the exception of the procedures for design change and design drawing, are located in the procedure “Design Development Control Procedures” (MDDQP-033, Rev.A, dated September 25, 2002). However, MDDQP-033 does not contain information that establishes the process your firm will follow to perform design verification.
 
B.   The design verification reports for design project VT-601, approved on September 5, 2011, do not include the names of the individuals that performed the design verification tests.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
4.    Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). 
 
For example, your firm has not validated the (b)(4) process it uses during the manufacture of its digital and infrared thermometers. When asked during the inspection, Mr. C.C. Jean, your firm’s General Manager, and Mr. S.F. Chiu, your firm’s Management Representative, both stated that the (b)(4) process has never been validated.
 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
5.    Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:
 
A.   Your firm’s CAPA Procedure, Control of Corrective and Preventative Action Procedure (MDDQP-023, Rev B1, dated May 21, 2003) does not require that potential corrective and preventive action investigations can be originated through the analysis of multiple sources of quality data (e.g., quality audit reports, complaints, quality records). Also, there is no requirement within the procedure that quality data be analyzed using appropriate statistical methodology, where necessary, to identify existing or potential causes of nonconforming product, or other quality problems.
 
B.   All of the supplier and quality control CAPA Reports (e.g., (b)(4)) reviewed during the inspection lacked any evidence to indicate that:
 
1.    Investigations into the causes of nonconformances were conducted,
2.    Actions needed to correct and prevent recurrence of the nonconformances were identified,
3.    Corrective or preventive actions taken were verified or validated to ensure that the action taken was effective and did not adversely affect the product,
4.    Changes in methods and procedures needed to correct and prevent the identified quality problems were implemented and recorded, and
5.    Information related to quality problems or nonconforming product was disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
6.    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:
 
A.   Your firm’s complaint procedure, Customer Complaints and Returns Control procedure, MDDQP-030, Rev A, dated March 12, 1999, does not include a requirement that complaints be evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting (MDR).
 
B.   A review of (b)(4) complaint records (e.g., complaint records dated 4/06/2011, 8/20/2010, and 7/30/2012) found that none of the complaints were evaluated to determine if the event was required to be reported to FDA as a MDR.  Also, none of these complaint records contained the device identification/control number or the address of the complainant.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
7.    Failure to establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation and disposition of nonconforming product, as required by 21 CFR 820.90(a). 
 
For example, your firm’s Nonconformity Process Control Procedure (MDDQP-021, Rev. B1, dated November 29, 2002) states that nonconforming materials found during production shall be put in the (b)(4). However, on October 15 and October 17, 2012, the investigator observed that subassemblies identified as nonconforming and awaiting rework were stored (b)(4)
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
8.    Failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance status and maintain the identification of acceptance status throughout manufacturing, packaging, labeling, installation, and servicing of the product to ensure that only product which has passed the required acceptance activities is distributed, used, or installed, as required by 21 CFR 820.86. 
 
For example, in-process printed circuit board subassemblies identified during the inspection by Mr. C.C. Jean and Mr. S.F. Chiu as “good” were observed by the investigator to be comingled in the assembly room with unmarked nonconforming subassemblies, and defective and broken components.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
9.    Failure to establish and maintain 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). 
 
For example, your firm’s Electrostatic Discharge (ESD) procedure (ASD-SOP-PZ-002, Rev A/0, dated September 4, 2008) indicates that workers should wear ESD wristbands and self-test (b)(4). However, during the inspection, multiple employees, including managers, at your firm were observed to be touching, holding, repairing, and (b)(4) in-process and reworked printed circuit boards and other electronic parts during thermometer assembly without using ESD wristbands or other means of proper ESD control. Also, those employees that were observed wearing ESD wristbands did not have the wristbands connected to the grounding rod.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
10.    Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example:
 
A.   The QC final test record for Lot (b)(4) of VT-601E infrared thermometers that were released for shipment to the United States on August 3, 2012, lacked the following information:
 
1.    Final blackbody temperature testing results. This testing, which is required to be performed prior to release, was not documented in the final test record. Mr. S.F. Chiu, your firm’s Management Representative, stated that blackbody testing is performed as a part of the Quality Control (QC) final test and final release. He also stated that the lot should not have been released with this missing test data.
2.    Blackbody temperature testing results in the Fahrenheit mode.
Mr. C.C. Jean, your firm’s General Manager, stated that the QC final test procedure (MDDQI-003, Rev A, dated December 10, 2009) requires that your firm’s QC unit conduct blackbody temperature tests at (b)(4) different temperature ranges using both the Celsius and Fahrenheit mode settings. However, according to Mr. S.F. Chiu, your firm’s Management Representative, your firm does not have a certified Fahrenheit measuring device. Therefore, your firm’s QC unit does not test the infrared thermometers using the Fahrenheit mode setting.
3.    Signatures indicating management review and approval of the lot prior to release.
 
B.   The QC final test record for Lot 0812 of VT-601D infrared thermometers that were released for shipment to Spain on October 12, 2012, lacked the following information:
 
1.    Final blackbody testing results, and
2.    Final blackbody temperature testing results in the Fahrenheit mode.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
11.    Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example:
 
A.   Your firm’s document control procedure, Document and Data Control, MDDQP-007, Rev A1, dated October 25, 2002, does not include a requirement that the date of document approval shall be documented.
 
B.   During the inspection, multiple procedures and records (e.g., Document and Data Control Procedure, Final Test Work Instruction for VT-601 infrared thermometers, ESD Procedure, ESD monitoring records, (b)(4) records, and CAPA records) were observed by the investigator to be lacking the required approval signatures and dates of approval. Also, changes made to these documents did not include the name or initial of the person making the change and the date of the change.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
12.    Failure to establish procedures for identifying training needs and ensuring that all personnel are trained to adequately perform their assigned responsibilities and document the performance of training, as required by 21 CFR 820.25(b). 
 
For example, Mr. C.C. Jean, your firm’s General Manager, stated that your firm’s sales department is responsible for evaluating and forwarding complaints. He also stated that the sales staff did not receive adequate consumer complaint and MDR training. A review of the training records for the (b)(4) individuals in your firm’s sales department that are responsible for evaluating and forwarding complaints confirmed that they did not receive training on your firm’s procedure for handling MDR’s (Vigilance Procedure, MDDQS-001) and your firm’s procedure for handling U.S. complaints (Customer Complaint & Notification Procedures for U.S. Clients, MDDQS-003, Rev A, dated May 20, 2009). 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated in its response that it promised to correct this observation and it provided a timeline for correction. However, in the response to this observation, your firm did not include any evidence to indicate that it has developed a corrective action plan, implemented a corrective action, and considered a systemic corrective action.
 
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 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 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 (including any systemic corrective actions) 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 Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #392309 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Ph.D. at 301-796-5770.
 
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 Inspectional 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. 
 
                                                                       
Sincerely yours,
/S/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
   Radiological Health
 
 
CC:
Mr. C.C. Jean
General Manager
Valeo Corporation, Taiwan
4F-3, No. 161 Sung-Teh Road
Taipei, Taiwan 110
 
Ms. Crystal Yu
Sales Specialist
Valeo Corporation, Taiwan
4F-3, No. 161 Sung-Teh Road
Taipei, Taiwan 110
 
Mr. S.F. Chiu
Management Representative
Grantech Co., LTD
No. 1 Area A, Shin Feng Cheng Ind. Park
Baoan District, Shenzhen
China