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U.S. Department of Health and Human Services

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Enforcement Actions

A & D Electronics (Shenzhen) Co., Ltd. 11/13/12

  

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
 
November 13, 2012
 
VIA UNITED PARCEL SERVICE
 
Takayuki Kohara
President
A&D Electronics (Shenzhen) Co., Ltd.
Tautouvillage, Songgang
Datianyang Industrial Zone
Baoan District, Shenzhen 519105
China
 
Dear Mr. Kohara:
 
During an inspection of your firm located in Baoan District, Shenzhen, China, on August 6, 2012, through August 9, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-invasive blood pressure monitors, bathroom scales, nebulizers, and digital 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 you, dated August 27, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that 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 establish and maintain procedures to include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing, and potential causes of nonconforming product or other quality problems and to employ appropriate statistical methodology, where necessary, to detect recurring quality problems, as required by 21 CFR 820.100(a)(1).  For example, your firm’s Corrective Action and Preventive Action (CAPA) Procedure (ADS-QB0216, Section 5.2.1.1) states that preventive action will be taken in response to analysis of quality data.  A preventative action plan will be submitted by the department responsible for the possible failure.  A department will be assigned to investigate and verify the corrective action. However, multiple issues identified in the 2011 data analysis of quality data did not result in a preventive action plan to document the investigation or verify/validate the results of the preventive action.  These issues include: (b)(4).
 
Your firm’s response dated August 27, 2012, is not adequate.  Your firm intends to correct the CAPA Procedure (ADS-WB0216) and to train personnel on the new CAPA procedure.  There is no mention of a retrospective evaluation of past corrective actions to determine if any investigations should be opened.  Your firm plans to provide an additional response to FDA on November 9, 2012, to include a copy of the revised document and training record.
 
2.    Failure to establish and maintain procedures to include requirements for investigating the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). For example, your firm’s management representative stated to the FDA investigator that your firm had not elevated any issues to the CAPA system.  However, serious issues exist at your firm that should have resulted in CAPA investigations, as described in your firm’s CAPA procedure (ADS-QB0216, Section 5.2.1.1).  These issues include:
 
  • Failure to open an investigation when the responsible division found that its materials and processes has defects (ADS-QB0216, Section 5.1.1.6).  Your firm’s (b)(4) supplier evaluation meeting noted (b)(4).  Your firm has a defect in the (b)(4) evaluation process, which did not result in a CAPA investigation as required by its procedures.
  • Failure to open an investigation for nonconformance found in Incoming/Outgoing Quality Control (IQC/OQC) (ADS-QB0216, Section 5.1.1.1).  Your firm had at least (b)(4) for nonconformance as a result of OQC, but had not documented a CAPA investigation plan for any of the nonconformances.
  • Failure to open an investigation for nonconformance found in Incoming/Outgoing Quality Control (IQC/OQC) (ADS-QB0216, Section 5.1.1.1).  Your firm made a modification to a (b)(4) as a result of an OQC, which was not elevated to a CAPA investigation, nor was a CAPA plan documented. 
 
Your firm’s response dated August 27, 2012, is not adequate.  Your firm plans to revise the Corrective Action and Preventive Action Procedure (ADS-WB0216) and to train personnel on the new CAPA procedure. There is no mention of a retrospective evaluation of past corrective actions to determine if any investigations should be opened in accordance with the CAPA procedure.  Your firm plans to provide an additional response to FDA on November 9, 2012, to include a copy of the revised CAPA procedure and personnel training record.
 
3.    Failure to establish and maintain procedures to include requirements for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).  For example:
 
  • Incoming Nonconforming Material Management Process (ADS-QW2100-01) requires inspection of (b)(4) lots to verify the effectiveness of corrective actions implemented as a result of OQC nonconformance.  If, within (b)(4), your firm does not receive (b)(4) lots of the affected component, then evaluation will be based on the (b)(4).  However, (b)(4) of (b)(4) OQC Quality Advice Notes reviewed by the investigator were closed without evaluating (b)(4) lots or waiting (b)(4) to evaluate the effectiveness of the corrective action.
  • (b)(4) Testing Process (ADS-QW0800-45) requires a test run upon return of the (b)(4) following a modification.  However, on March 29, 2011, the (b)(4) was modified as a result of an OQC Quality Advice Note and no documentation exists that the repaired (b)(4) was inspected or tested prior to use in production.
 
The adequacy of your response dated August 27, 2012, cannot be determined at this time.  Your firm plans to correct the Corrective Action and Preventive Action Procedure (ADS-WB0216) and to train personnel on the new CAPA procedure.  The revised CAPA procedure was not provided. Your firm plans to provide an additional response to FDA on November 9, 2012, to include a copy of the revised CAPA procedure and personnel training record.
 
4.    Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, and document the evaluation, as required by 21 CFR 820.50(a)(1).  For example, your firm’s Supplier Evaluation and Performance Tracking Procedure (ADS-QW0701-03, Section 4.1.1) requires an initial evaluation to be conducted between purchasing, technical, and quality control divisions, with the results collected in the supplier’s record.  However, (b)(4) of the (b)(4) supplier records reviewed by the investigator include documentation of the initial evaluation as described in your firm’s procedure. Additionally, your firm did not document the evaluations of (b)(4) suppliers, rated at the (b)(4) level between (b)(4) through (b)(4), as required by your firm’s Supplier Evaluation and Performance Tracking Procedure (ADS-QW0701-03, Section 4.8). 
 
The adequacy of your firm's response cannot be evaluated at this time. Your firm intends to revise the Supplier Evaluation and Performance Tracking Procedure (ADS-QW07001-03) and train employees on the updated procedure.  However, it is unclear what actions will be taken by your firm for its supplier records that lack initial evaluation documentation. Additionally, your firm stated that it currently conducts (b)(4) meetings, which will include discussions of the (b)(4) level suppliers.  It intends to revise the Supplier Evaluation and Performance Tracking Procedure (ADS-QW07001-03) and train employees on the updated procedure.  Your firm plans to provide an additional response to FDA on November 9, 2012, to include a copy of the revised Supplier Evaluation procedure and personnel training record.
 
5.    Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).  For example, the (b)(4) Testing Process (ADS-QW0800-45) requires a test run upon return of the (b)(4) following modification; a “(b)(4)” is to be recorded.  Your firm could not provide documentation of a test run or (b)(4) history following the (b)(4) repair on March 29, 2011, for (b)(4).
 
The adequacy of your firm’s response dated August 27, 2012, cannot be determined at this time.  Your firm notes that it will update the (b)(4) Testing Process (ASDS-QW0800-45) and provide personnel with training to ensure a test run is conducted and documented after modification to the (b)(4).  Your firm plans to provide an additional response to FDA on November 9, 2012, to include a copy of the revised (b)(4) Testing Process document and personnel training record.
 
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 #360078 when replyingIf you have any questions about the contents of this letter, please contact: Daniel Walter at (301) 796 – 5587 (telephone) or (301) 847 – 8138 (fax).
 
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