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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Accuron Technologies (Dornier Medtech Systems GmbH ) 8/26/11

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993

AUG 26, 2011

VIA United Parcel Service and Facsimile

Lok Chuk Yam
President and CEO
Accuron Technologies
2 Corporate Place
Singapore 618494
 
Dear Mr. Yam:

During an inspection of your firm located in Wessling, Germany, on April 26, 2011, through April 29, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures extracorporeal shock wave lithotripsy device systems.  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.

Our inspection revealed that your devices are 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 devices that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. 

We received a response from your firm dated May 18, 2011, and an undated response that was received on June 21, 2011, concerning our investigators’ observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to you.  We address the responses below, in relation to each of the noted violations.  In addition, we received your August 12, 2011, response; however, it was not reviewed because it was not received within fifteen business days of issuance of the Form FDA 483.  This response may 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 develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.  For example:

a. Your firm’s MDR procedure does not describe an internal system that provides for:

• timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
• a standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
• timely transmission of complete medical device reports to manufacturers or to FDA, or to both if required.

b. Your firm’s MDR procedure does not describe how your firm will document and maintain records, such as:

• documenting information that was evaluated to determine if an event was reportable;
• maintaining records of all medical device reports and information submitted to manufacturers and FDA; and
• describing a system that ensure access to information that facilitates timely follow-up and inspection by FDA.

Your response dated May 18, 2011, is not adequate. You provided a revised version of your firm’s MDR Procedure; however, the revised version does not meet the requirements of 21 CFR 803.17 as stated above.

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.
 
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. 

In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S.C. 351(h)), which are deficiencies of the following Current Good Manufacturing Practice requirements of the Quality System regulation found at 21 CFR Part 820.  These nonconformities include, but are not limited to, the following:

1. Failure to establish and maintain adequate procedures for validating the device design and for documenting in the Device History File (DHF) the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, as required by 21 CFR 820.30(g).  For example, your firm’s design validation procedure titled, Clinical Test Stock No. K1011215, was not implemented for the MC4 Design Project and, subsequently, the results of the design validation, including identification of the design, methods, the date, and the individuals performing validation were not adequately documented in the DHF.  In addition, acceptance criteria were not established prior to the performance of validation activities.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has  revised its design validation procedure and renamed it K1011215, Clinical Test (Design Validation).  This revised procedure requires the following: (1) design validation will be performed per an approved written test protocol, which will include the acceptance criteria for all of the tests performed; (2) design validation will include software validation and risk analysis where appropriate; and (3) all results of the design validation will be documented in the design history file to include at a minimum the identification of the design validated, validation methods, validation results, date of validation, and persons performing the validation.  Training records to demonstrate that employees were trained on the revised procedure were also submitted.  In addition, you are performing an additional clinical test/design validation for the MC4 project in accordance with the revised procedure, and the appropriate documentation will be placed in the DHF.

2. Failure to establish and maintain adequate procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example, no documentation of design change control procedures was available for the design change process used to control the design changes resulting from validation testing in the Design Project MC4 just prior to design transfer.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has developed a new procedure K1034471, Design Change Control – Prototype Phase.  This new procedure defines the mechanism that will be used to control design changes that occur during the prototype phase of the design and development process and ensures that: (1) all design changes for new products prior to serial production will be identified, documented, verified where appropriate, validated, and reviewed prior to implementation; and (2) all changes will be thoroughly documented to show that corrective actions are tracked to completion and that changes are implemented in a manner that corrects the problem without creating new or additional concerns.  Training records to demonstrate that employees were trained on the new procedure were also submitted.  In addition, a revalidation of the MC4 project is being performed and any subsequent changes made as a result of the revalidation will be controlled using the new change control procedure.  Also, a review of all changes during the MC4 project will be performed and, where possible, the master design change log will be updated in accordance with this new procedure.

3. Failure to establish and maintain adequate procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).  For example, your Product Design procedure, Stock No. K1011216, was not implemented for Design Project MC4.  The Design Transfer Review meeting is required by procedure to be completed prior to design transfer; however, production of serial units was initiated prior to the Design Transfer Review meeting.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has revised its Product Design, K1011216, procedure to ensure that proper controls are in place during the design transfer stage so that the device design is correctly translated into production specifications.  Your firm has also developed a Design Transfer Checklist that will ensure that all critical elements of the design transfer process are completed, reviewed, approved, and documented.  Training records to demonstrate that employees were trained on the revised procedure were also submitted.  In addition, your firm will perform an additional Design Transfer Review meeting once the revalidation of the final design is completed.

4. 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 Complaint and Corrective and Preventive Actions (CAPA) procedure, Stock No. K1017164, does not include requirements for: analyzing all sources of quality data to identify existing and potential causes of nonconforming product or other quality problems; using appropriate statistical methodology, where necessary; verifying and validating corrective and preventive actions; or implementing and recording changes necessary to correct and prevent identified quality problems.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has created a new CAPA procedure, Stock No. K1034450.   This procedure now includes requirements for analyzing all sources of quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary; verifying and validating corrective and preventive actions; and implementing and recording changes necessary to correct and prevent identified quality problems.  Training records to demonstrate that employees were trained on the new procedure were also submitted.

5. Failure to document all activities required under 21 CFR 820.100, and their results, as required by 21 CFR 820.100(b).  For example, your firm’s Complaint and CAPA procedure, Stock No. K1017164, does not ensure that all activities are documented and included or referenced in the CAPA files, including investigating the cause of nonconformities; identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems; verifying and validating corrective and/or preventive actions; and implementing and recording changes necessary to correct and prevent identified quality problems.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has created a new CAPA procedure, Stock No. K1034450.  In addition, your firm has revised its CAPA investigation template, which ensures that all activities are documented and included or referenced in the CAPA files to include investigating the cause of nonconformities; identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems; verifying and validating corrective and/or preventive actions; and implementing and recording changes necessary to correct and prevent identified quality problems.  Training records to demonstrate that employees were trained on the new procedure and the revised CAPA investigation template were also submitted.

6. 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 Complaints and CAPA procedure, Stock No. K1017164, does not ensure that: complaints are processed in a uniform and timely manner; oral complaints are documented upon receipt; and complaints are evaluated for MDR reportability.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has revised its Complaint Procedure, K1017164, to ensure that all requirements of 21 CFR 820.198 are addressed.  More specifically, the revised procedure now ensures that complaints are processed in a uniform and timely manner; oral complaints are documented upon receipt; and complaints are evaluated for MDR reportability.  Training records to demonstrate that employees were trained on the revised procedure were also submitted.

7. Failure to adequately maintain (by a formally designated unit) a record of investigation when an investigation is made under 21 CFR 820.198, as required by 21 CFR 820.198(e).  For example, your firm’s Complaints and CAPA procedure, Stock No. K1017164, does not ensure that all of the required information is retained in the complaint records when an investigation is conducted, including the date the complaint was received, the dates and results of the investigations, any corrective actions taken, and any replies to complainants.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has revised its Complaint Procedure, K1017164, to ensure that all requirements of 21 CFR 820.198 are addressed.  More specifically, the revised procedure now ensures that all of the required information is retained in the complaint records when an investigation is conducted, including the date the complaint was received, the dates and results of the investigations, any corrective actions taken, and any replies to complainants.  Training records to demonstrate that employees were trained on the revised procedure were also submitted.

8. Failure to establish adequate procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities and to document such training, as required by 21 CFR 820.25(b). For example, training procedures have not been adequately defined and documented to ensure that employees are trained to adequately perform their assigned responsibilities and to ensure the training is documented.

Your response dated May 18, 2011, and your undated response appear to be adequate.  Your firm has a general SOP training procedure, K1024447; however, as a result of this observation, your firm created a new training SOP, K1034470, which targets the training of manufacturing employees.  This new procedure is intended to ensure that manufacturing employees are trained to adequately perform their assigned responsibilities and to ensure that such training is documented.  It also clarifies how personnel are to be trained on revisions to applicable manufacturing/test instructions and how that training will be documented.  Training records to demonstrate that employees were trained on the new procedure were also submitted.  In addition, your firm has reviewed all employees training records on manufacturing/test instructions and provided any re-training that was needed.

Your firm’s response to this Warning Letter 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 #203432 when replying.  If you have any questions about the contents of this letter, please contact:  Mr. Paul F. Tilton at 301 796-5770 or by fax at 301-847-8137.
 
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, Form 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