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U.S. Department of Health and Human Services

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Nissei Precision Instruments (Suzhou) Co., Ltd 10/10/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire A venue
White Oak Building 66
Silver Spring, MD 20993

OCT 10, 2012

WARNING LETTER


 
Mr. Hideki Kudo
General Manager
Nissei Precision Instruments (Suzhou) Co., Ltd
Zuzhou National Environmental New & Hi-tech Industrial Park
No. 369 Lushan Road
Suzhou, China 215129

Dear Mr. Kudo: 

During an inspection of your firm located in Suzhou, China, on June 25, 2012, through June 28, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures a wrist blood pressure monitor, model number WSK-1011.  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 July 11, 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 adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).  For example, your firm’s procedure document QP23, Rev. A/0, Corrective and Preventive Action Control, does not:

a. Describe or reference methods to analyze sources of quality data for existing and potential causes of nonconforming products.  According to section 4.1.2 (Significant Improvement) of the procedure, when considering a change to an existing process or product, analysis of existing process conditions should be considered.  However, the procedure fails to define types of data and methods for such an analysis.
b. Address the use of statistical methodologies to detect recurring problems.  For example, (b)(4).  However, the procedure fails to describe how this information is captured into a Corrective and Preventive Action (CAPA).
c. Adequately address implementation of corrective actions.  For example, CAPA report number 2011-6 was closed prior to corrective actions being implemented.
d. Adequately address verification or validation of corrective actions.  A review of your firm’s CAPA report numbers 2011-5 and 2011-6 indicates that validation included review of (b)(4) lot for no nonconformities.  However, there was no justification for the review of (b)(4) lot for these validation activities

We reviewed your firm’s response and conclude that it is not adequate.  Your firm did not provide details of the revisions to procedure QP21, Non-conformity article control procedure; procedure QP22, Statistical Analysis and Control Procedure; and procedure QP23, Improvement Control Procedure, and your firm failed to indicate how these revisions will address the deficiencies.  Also, the response did not include revised procedures for our review.  Further, your firm did not indicate whether it considered a systemic correction to review all existing CAPAs to ensure that corrective and preventive actions put in place are effective.

2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).  For example, your firm’s complaint handling procedure document QP17, Rev. A/0, Customer Feedback Control Procedure, does not:

a. Adequately designate a formal unit to review and evaluate complaints.
b. Require complaints to be evaluated to determine whether a complaint represents an event that is required to be reported to FDA under 21 CFR Part 803, Medical Device Reporting.  The following complaints reviewed during the inspection lacked an medical device reporting evaluation: Complaint numbers 2011-4, 2011-5, and 2011-6.
c. Require complaint files to be maintained for all received complaints.  During the inspection, your firm’s General Manager, Mr. Kosuge, indicated that the complaints deemed insignificant or invalid upon initial review are not documented as complaints.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm did not indicate its plan to evaluate existing complaints against the revised procedure or actions that it may take based on such a review.

3. Failure to review and evaluate all complaints to determine whether an investigation is necessary and, when no investigation is made, failure to maintain a record that includes the reason that no investigation was made and the name of the individual responsible for the decision not to investigate, as required by 21 CFR 820.198(b).  For example, your firm’s complaint handling procedure document QP17, Rev. A/0, Customer Feedback Control Procedure, does not require documentation of the reason why no investigation was conducted when an investigation is deemed not necessary.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm did not indicate its plan to evaluate existing complaints against the newly revised procedure or actions that it may take based on such a review.

4. Failure to ensure, 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 procedures, as required by 21 CFR 820.75(a).  For example, your firm’s process validation procedure document QP12, Rev. A/0, Verification Control Procedure for Production and Service Offering Process, does not require validation of any processes or equipment with the exception of (b)(4). There is no documentation that the (b)(4) and the (b)(4) are validated.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm did not provide any documentation indicating that it has reviewed all existing production equipment and processes to ensure that they were validated according to an established protocol and were deemed capable of meeting the pre-established requirements.  In addition, your firm did not provide any documentation describing actions it may take based on such review.

5. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g). For example:

a. Inspection procedures for the (b)(4) and (b)(4) have not been established.
b. Maintenance schedules have not been developed for all manufacturing equipment, including the (b)(4).  Specifically, document number QP06, Rev. A/0, Basic Equipment Control Procedure, includes a maintenance schedule for the production equipment.  However, it did not include the (b)(4).  Your firm’s General Manager, Mr. Kosuge, indicated that your firm does not have a maintenance procedure for the (b)(4).

We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response did not indicate whether a review of all existing production equipment was conducted to ensure that required equipment has undergone maintenance to ensure that the devices produced using them conform to their specifications.  In addition, your firm did not provide a documented rationale for situations when maintenance is not deemed necessary.

6. Failure to establish and maintain adequate procedures for the use and removal of manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device’s quality, as required by 21 CFR 820.70(h).  For example, your firm lacks a procedure or process that addresses the use and removal of manufacturing material that may have an adverse effect on product quality.  According to CAPA number 2011-4, (b)(4) non-conformities were observed due to (b)(4).  However, your firm did not have any procedure that described a process for (b)(4).

We reviewed your firm’s response and conclude that it is not adequate.  Your firm did not provide any details of the update to procedure QP23, the expected implementation date, or how it plans to check whether the modifications were effective.

7. Failure to establish and maintain adequate procedures to control all documents that are required by 21 CFR Part 820.40.  For example, (b)(4) are used to document approval of production procedures, CAPA reports, and finished device acceptance.  (b)(4) of various employees were observed together in an (b)(4) in the quality management room.  However, your firm does not have an established procedure that provides a process to control such (b)(4)

We reviewed your firm’s response and conclude that it is not adequate.  Procedure “(b)(4) Control Procedure” was not included with the response for our review.  Further, your firm did not indicate that it conducted a review of all existing documents to ensure that the (b)(4) were used in appropriate manner to represent an approval from the individual.

8. Failure to establish and maintain adequate procedures for identifying valid statistical techniques for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a).  For example, your firm does not have a procedure that identifies the statistical technique used during the analysis of the “(b)(4)” to identify defective components.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s “General Inspection procedure” was not included with the response for our review.  Further, your firm did not indicate whether it conducted a review of all existing processes and procedures to ensure that the statistical techniques, when used, are valid for the purpose.

9. Failure to establish and maintain adequate procedures to ensure that sampling methods are adequate for their intended use and to ensure that, when changes occur, the sampling plans are reviewed, as required by 21 CFR 820.250(b).  For example:

a. There is no rationale for the sampling plan used to verify and validate CAPA activities.  Verification activity for CAPA numbers 2011-5 and 2011-6 included review of (b)(4) lot for non-conformities.  However, your firm was unable to provide a documented statistical rationale demonstrating that a sample size of (b)(4) lot is appropriate for such verifications.
b. There is no rationale for the sampling plan used in the process qualification of the wrist blood pressure monitor, model WSK-1011.  The process qualification included a run of (b)(4) production equivalent units. However, your firm was unable to provide a documented statistical rationale demonstrating that a sample size of (b)(4) units is appropriate for such qualification.
c. There is no rationale for the sampling plan used in the (b)(4) test and the (b)(4) test for the finished device test of the wrist blood pressure monitor, model WSK-1011.  According to the document WI-004, Product Inspection Standard, (b)(4) tests are carried out using a sample size of (b)(4) units.  However, your firm was unable to provide a documented statistical rationale demonstrating that a sample size of (b)(4) units is appropriate for such testing.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s “General Inspection procedure” was not included with the response for our review.  Further, your firm did not indicate that it conducted a review of all existing processes and procedures that utilize sampling plans to ensure that they are adequate for their intended use.

10. Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.  For example, your firm has not established a DMR for the wrist blood pressure monitor, model WSK-1011, that includes or references approved device specifications, production process specifications, quality assurance procedures and specifications, packaging specifications, and labeling specifications.

The adequacy of your firm’s response cannot be determined at this time.  A copy of the DMR procedure was not included with the response for our review.

11. Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184.  For example, your firm does not have a procedure that provides a process to maintain DHRs. Further, a review of the DHRs for the device serial numbers (b)(4) through (b)(4) indicated that they did not include or refer to the location of the primary identification label or the labeling used to identify each production unit.

We reviewed your firm’s response and conclude that it is not adequate.  Details related to the revision to the procedure QP13, or the revised procedure, were not provided for our review.  Further, your firm did not indicate whether it conducted a review of all existing DHRs to ensure that they contain or refer to the required information.

Our inspection also revealed that your firm’s wrist blood pressure monitor, model WSK-1011, is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.  Significant violations include, but are not limited to, the following:

Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.  For example, your firm does not have a procedure to address Medical Device Reporting.

We reviewed your firm’s response and conclude that it is not adequate.  Your firm did not provide any information as to its plan for evaluating existing complaints against the yet to be established MDR procedure, and actions it may take based on such an evaluation.

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 number 360540 when replying.  If you have any questions about the contents of this letter, please contact: Joshua Simms at (301) 796-5599.
 
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