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Enforcement Actions

Interacoustics A/S 12/10/09

   

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

 


DEC 10 2009


WARNING LETTER


VIA FEDERAL EXPRESS


Arne Boye Nielsen
General Manager, President-Diagnostics Instruments
Interacoustics A/S
8 Drejervaenget
Assens, Denmark DK-5610


Dear Mr. Nielsen:


During an inspection of your firm located in Assens Denmark on June 22 through June 25 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures audiometers and advanced diagnostic and clinical products. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 32] (h), these products are devices because they are intended for use in the diagnosis of a 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.


The 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 (CFR), Part 820. We received a response from Arne Boye Nielsen dated September 07, 2009 concerning our investigator's observations noted on the Form FDA 483 List of Inspectional Observations that was issued to you. 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 finished device acceptance activities, as required by 21 CFR 820.80(d).


For example, during review of Final Acceptance Testing, the inspector requested records of final finished device acceptance activities used to assure that all medical devices manufactured at the firm conform to specified requirements contained within the Device Master Record (DMR). There are no defined and documented procedures for final finished device acceptance.


The firm's response dated September 07, 2009 is not adequate. The response did not include a copy of the procedure for finished device acceptance activities or documentation of training related to the implementation of this procedure. Also, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


2) Failure to establish and maintain adequate procedures for implementing corrective and preventive action including identifying the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a).


For Example, the firm's procedure for Corrective and Preventive Action, (b)(4), requires the assigned person, performing the investigation, to document he determination of the corrective action, as well as the assigned person's name and the date of the determination. The procedure also requires that after the investigation is completed, the details of the activities taken in order to prove that the corrective action addresses the initial problem are to be documented. However, during the inspection it was observed that records associated with corrective actions did not document that a corrective action was conducted to prevent reoccurrence of nonconforming product and other quality problems.

 

The firm's response dated September 07, 2009 is not adequate. The response did not include the revision to (b)(4) which includes examples of minimum requirements for documenting corrective and preventive actions. The response also did not include documented personnel training on the revised procedure for documenting corrective and preventive actions nor documentation demonstrating that the Quality Manager will follow up on a regular basis to ensure the data is documented correctly. Finally, the response did not include a description and evidence of nonconformity.


3) Failure to establish and maintain an adequate procedure which ensures an investigation into the causes of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2).


For example, the firm's CAPA procedure, (b)(4) specifics that when an investigation is completed and a corrective action is implemented, the verification action taken in order to prove that the corrective action actually addressed the initial problem is to be documented. However, CAPA procedure (b)(4) does not contain sufficient provisions to ensure that an investigation of the root cause(s) of nonconformities be conducted so that appropriate corrective actions can be implemented.


The firm's response dated September 07, 2009 is not adequate. The response did not include the revision to CAPA procedure, SOP # (b)(4) including the root-cause template which is intended to address this observation. The response also did not include documented personnel training on the revised procedure. Finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.

4) Failure to maintain an adequate record of the investigation of a complaint by a formally designated unit, as required 21 CFR 820. 198(e).


For example, complaint # which references a FireWire camera (b)(4) device describes that the vertical movement of lens on the camera goes in steps and not linear. The corrective action was to mechanically adjust the camera to align the eyes horizontally. The project manager investigated the problem, discovered a fix and closed the complaint. However, no documentation was created regarding the investigation.


The firm's response dated September 07,2009 is not adequate. The response did not include documentation of procedural revisions to ensure complaints are appropriately recorded or personnel training on the subject. Also, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


5) Failure to establish and maintain an adequate procedure 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, as required by 21 CFR 820.100(a)(1).


For example, records of nonconformities associated with raw material incoming acceptance activities are not analyzed to identify existing and potential causes of nonconforming product or other quality problems.


During review of receiving inspection records, our investigator recognized that two shipments of a critical part, (b)(4) were rejected due to an output that was (b)(4). The issue was further documented in Complaint #(b)(4)-0utput is low@ 250 Hz, min 10 dB too low. Between December 2008 and February 2009, several emails were sent between the Compliance Supervisor and supplier regarding the issue and it was agreed that an initial specification would be submitted to the supplier in order to correct the problem.


Quality data trend analyses are conducted (b)(4) times per year per a CAPA meeting. Nonconformities associated with raw material incoming acceptance activities are not captured for analysis during these meetings (e.g. December 2008, January 2009).


The firm's response dated September 07, 2009 is not adequate. The response did not include revisions to procedure SOP#(b)(4) nor documentation that your firm has reviewed quality data sources to ensure appropriate data/results are recognized and analyzed by the CAPA system. The response did not include documentation of the establishment of instructions on how to evaluate and report data/results from each quality data source. Also, the response did not include documented training of personnel on proper record handling to ensure the reliability of the data contained within the record. Finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


6) Failure to establish and maintain an adequate procedure to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).

 

For example, the firm's procedure (b)(4) for Nonconforming Products requires the identification, documentation, segregation, evaluation and disposition of nonconformities. However, during the current inspection it was found that evaluations, investigations, and dispositions associated with nonconformities identified in the Nonconformities Log for 2007-2009 for the products, TITAN, Eclipse/ASSR and VNG were not documented.

 

The firm's response dated September 07, 2009 is not adequate. The response did not include the revised procedure SOP #(b)(4) which includes the production flow for all tests to ensure that a test instruction is available. Also, the response did not provide documented evidence that your firm will document and evaluate nonconformities identified during production, including the documentation of nonconformity dispositions. Finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


7) Failure to establish and maintain adequate acceptance procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall documented, as required by 21 CFR 820.80(b).


For example, the firm's procedure for Receiving Inspection and Stock Handling (SOP#(b)(4)), states that nonconformities involving deviations in packaging or state of goods must clarified with the supplier using the Nonconformity Report Form #(b)(4) In addition, deviations concerning number, type and large deviations on quantity must be clarified with the purchase department. However, receiving reports #(b)(4), document that two shipments of were rejected at incoming acceptance for failure to comply to specified requirements. A Nonconformity Report Form #(b)(4) was not completed to document either of these nonconformities.


The firm's response dated September 07, 2009 is not adequate. The response did not include the revised procedure SOP #(b)(4) , "Receiving inspection and stock handling" addressing this issue and the response did not include documented evidence of additional training with respect to the revised procedure. Also, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


8) Failure to establish and maintain an adequate procedure that evaluates and selects potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 CFR 820.50(a)(1).

For example, the firm's supplier procedure, Evaluation of Suppliers (SOP #(b)(4)), states that all (b)(4) critical component suppliers will have an initial supplier evaluation form, addition, the Purchase Manager will evaluate all suppliers classified as (b)(4) minimally once a year. However, review of purchasing records associated with three suppliers (b)(4) of approved, critical components (Category (b)(4)) revealed that the annual supplier evaluations were not conducted. 

 

The firm's response dated September 07, 2009 is not adequate. The response did not include documentation of the results of the review of procedure SOP# (b)(4). The response did not include documentation of the evaluation of suppliers of (b)(4) critical components. Also, the response did not provide documented evidence of training regarding the correction of this observation. finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity. 

 

9) 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:

 

A. Our investigator observed that during a (b)(4) product software upgrade to (b)(4), approximately 5 variations and 64 batches of (b)(4) products containing the revised software were released for distribution prior to the completion of testing associated with the upgrade;
B. SOP #(b)(4), states that if a design change is implemented, a validation plan and risk assessment should be performed. However, our investigator observed that approximately seven design change ECO(s) with verification completed did not have validations and there was no explanation of the lack of validation; and
C. No design change procedure (e.g.(b)(4) contains provisions specifying when design verification can be performed in lieu of validation prior to implementation of a design change.


The firm's response dated September 07,2009 is not adequate. The response did not include a revised version of the product design control procedure (b)(4) that will: (1) specify validation and regression testing after software changes; and (2) include provisions for when design change verification is sufficient in lieu of validation. The response did not include a copy of the device change form that will address the needs for verification and validation. Also, the response did not include documented evidence of the training of project managers and software developers in the use of the revised procedure. Finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


10) Failure to monitor and control process parameters and component and device characteristics during production, as required by 21 CFR 820.70(a)(2).

 

For example. the firm's nonconformance Log for 2007-2009 for Titan, Eclipse/ASSR and VNG products contains a list of nonconformities recorded during production processing. The information in this log is not reviewed to discern if the nonconformities in production and process parameters affect the capability to manufacture the medical device to designated specifications.

 

The firm's response dated September 07, 2009 is not adequate. The response did not include documentation of your plan to check the production flow for monitoring of process parameters and component and device characteristics. Also, the response did not include documented evidence that nonconformities identified during production and their respective corrections will be documented. Finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.

 

Our inspection also revealed that your audiometers and advanced diagnostic and clinical products are misbranded within the meaning of section 502(t)(2) of the Act [21 U.S.C. § 352(t)(2)], in that your firm failed to justify the lack of reporting of correction or removal action to FDA which shall contain conclusions and any follow-ups, and be reviewed and evaluated by a designated person, as required by 21 CFR 806.20(b)(4). For example, review of the CAPA system revealed that Correction and Removals were conducted for the software on the ECLIPSE/ASSR system. The (b)(4) describes a software error that does not allow the serial number to be read in order to operate the system. Complaints regarding this issue were noted on the "Incident list Product Focus" list, or complaint Log and a notice was sent to all distributors of the device and kept in the database, However,, there was no documentation in the database, or the actual file, stating a justification for not reporting the correction or removal action to FDA including conclusions by a designated person. 


The firm's response dated September 07, 2009 is not adequate. The response did not include a copy of the revised procedure SOP #(b)(4) Also, the response did not include the modified Form (b)(4) that has been changed to include justification for whether or not to report correction or removal action to FDA. The response did not include the documented training addressing this specific issue. Finally, the response did not include a description and evidence of implementation of the corrective action in order to eliminate the cause of the existing nonconformity.


You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381 (a). 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. If the documentation is not in English, please provide a translation to facilitate our review.


Your response should be sent to Ronald Swann, Braneh Chief, U.S. Food and Drug Administration. 10903 New Hampshire Avenue, WO66-3534, Silver Spring, MD 20993. If you have any questions about the content of this letter please contact Ronald Swann at 301-796-5770, or ronald.swann@fda.hhs.gov.


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 laws and regulations administered by FDA. The specific violations 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 systems. 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.


Sincerely,

/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Device and
Radiological Health