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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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NovaLung Gmbh 4/2/12

  

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 

 

APR 2, 2012
 
 WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Josef Bogenschutz
Co-Managing Director
Novalung GmbH
Benzstr. 4-7
Oberstenfeld, Germany
 
Dear Josef Bogenschutz:
 
During an inspection of your firm located in Oberstenfeld, Germany, on November 14, 2011, through November 17, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Novalung Surgical Lung Assist (sLA).  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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 this device is 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, its 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 November 23, 2011, 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 that include requirements for verifying or validating the corrective and preventive action (CAPA) to ensure that such action is effective and that it does not adversely affect the finished device as required by 21 CFR 820.100(a)(4).
 
For example, at least seven of the eleven CAPAs/non-conformances (failures) that were reviewed by the investigator lacked documentation to demonstrate the adequacy of effectiveness checks.  Examples include failures (b)(4).  Your firm failed to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device. A representative at your firm indicted that all nonconformances are considered CAPAs and handled according to CAPA VA-08-06.
 
We reviewed your firm’s response and conclude that it is not adequate.  The response included identifying a responsible person for the completion of the retrospective differentiation, identification of real CAPAs, and effectiveness checks of identified CAPAs by March 31, 2012.  The response is not adequate because your firm has not implemented correction or corrective action.  In addition, your firm did not provide documentation that it has investigated its complete CAPA subsystem or that a systemic corrective action was considered.
  
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 failed to process non-conformances (failures) and customer feedback reports as complaints.  As such, they were not included in complaint files nor reviewed, evaluated, or investigated.  Your firm’s representatives, (b)(4), stated that your firm does not assess or evaluate customer feedback reports for complaints.  Examples include the nonconformance (b)(4), dated January 13, 2009, the nonconformance (b)(4), dated January 06, 2011, the customer feedback (b)(4), dated January 22, 2010, the customer feedback (b)(4), dated April 18, 2011, and the customer feedback (b)(4), dated April 18, 2011.  These device problems were reported after the devices were released for distribution, as indicated by your firm’s representative, (b)(4), and are therefore not considered complaints.  These examples were either on a list of consumer feedback reports or they were on a list of CAPA/non-conformances (failures), but they were not on the list of complaints or a part of the complaint files that were evaluated per your firm’s complaint procedures.  Your firm’s representatives, (b)(4), stated that your firm failed to recognize the reports as complaints.
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response included identifying a responsible person and a target date for several proposed measures.  The response is not adequate because your firm has not implemented correction or corrective action. In addition, your firm has not provided documentation that it investigated its entire complaint subsystem or considered a systemic corrective action.
 
3.    Failure to establish and maintain an adequate design history file (DHF) for each type of device that shall contain or reference the records necessary to demonstrate that the design was developed in accordance with an approved design plan and the requirements of Part 820, as required by 21 CFR 820.30(j).  For example:
  
a.    The redesigned (b)(4) DHF did not contain drawings or refer to the location of the drawings for the original design of the (b)(4) or the design drawings for the (b)(4) after the re-design project, (b)(4).
 
b.    The DHF for the (b)(4) re-design project (b)(4) did not contain any reference to (b)(4) and only referred to (b)(4) in the design files included as part of the DHF.  Comparisons were not made to explain the similarities or differences between the (b)(4). Examples of documents in the design history file that only refer to the iLA include the (b)(4) dated May 04,2009, (b)(4), the (b)(4) approval dated June 15, 2009, (b)(4), and the (b)(4) dated June 15, 2009, (b)(4).
 
c.    The (b)(4) failure mode effect analysis (FMEA) documents (including (b)(4)) included in the DHF, which were provided by your firm’s representative, (b)(4), only referenced the (b)(4). There were no references to the (b)(4) device in any of the FMEAs provided as indicated in the DHF for the redesigned (b)(4)       
 
We reviewed your firm’s response and conclude that it is not adequate.  The response included identifying a responsible person and a target date for several measures to be completed.  The response is not adequate because your firm has not implemented correction or corrective action.  Also, your firm did not provide documentation that it has investigated the entire DHF subsystem or that it considered a systemic corrective action. In addition, your firm did not provide documentation that it will train employees on the new design transfer procedure.
 
4.    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, your firm did not adequately document procedures for design changes to the tubing on the redesigned (b)(4).  Change Request (b)(4), which (b)(4) stated initiated design changes to the (b)(4), and which was approved on May 20, 2008, did not contain any reference to the (b)(4) design.
  
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response included identifying a responsible person and a target date for several measures to be taken.  The response is not adequate because your firm has not implemented correction or corrective action.  Also, your firm has not provided documentation that it has investigated the entire design change subsystem and that it has considered a systemic corrective action.  In addition, your firm did not provide documentation that it will train employees on the new Design Change Procedure.
 
5.    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 firm failed to provide documentation, upon the request of the investigator, that the production assembly drawings for the redesigned (b)(4) are the same drawings that were approved as part of the design output and design transfer process.  The (b)(4) assembly drawings lacked revision dates and approval signatures or they contained unapproved e-signatures.
  
We reviewed your firm’s response and conclude that it is not adequate because your firm has not implemented correction or corrective action.  Also, your firm has not provided documentation that it has investigated its entire design transfer subsystem to ensure that design transfer deficiencies would not recur and that it has considered a systemic corrective action.  In addition, your firm did not provide documentation of employee training on the new design transfer procedures.
 
6.    Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40.  For example, your firm did not adequately establish document control procedures for documents unrelated to production or engineering changes.  (b)(4) dated January 28, 2010, does not include an adequate procedure for tracking and storing the status of in process change control of QM forms, work instructions, and other materials that are unrelated to production, engineering changes, or customer requirements. No written documentation is required to be maintained of the requestor or reviewers. Nor is there a requirement to document quality circle approval and there is no requirement for identification of affected documents.
  
We reviewed your firm’s response and conclude that it is not adequate because your firm did not implement correction or corrective action.  Also, your firm has not provided documentation that it conducted an investigation of the entire document control subsystem to ensure that all documents are controlled and that the problem does not recur and that you have 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 #269798 when replying.  If you have any questions about the contents of this letter, please contact: Charles Cathlin at (301) 796-5548 or via facsimile at (301) 847-8128.
 
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