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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Oertel Medical GmbH 6/11/12

  

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 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Ms. Annette Oertel
General Manager
Oertel Medical GmbH
Postfach 110
D-78532, Tuttlingen, Germany
 
Dear Ms. Oertel:
 
During an inspection of your firm located in Tuttlingen, Germany, on January 25, 2012, through January 27, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-powered endoscopic grasping/cutting instruments. 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 responses from you dated February 7, 2012 and February 24, 2012,concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses 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:
 
a) The CAPA procedure, “Messung, Analyse und Verbesserung (ver 1;01.03.2007),” does not establish requirements for analyzing several significant sources of quality data such as rework, product processes, and quality audits. Specifically, the procedure does not require analysis or documentation of rework or other sources of quality data. There is no requirement for implementing and recording changes in methods and procedures for corrective and preventive actions. The procedure does not require information to be disseminated to responsible individuals.
 
b) The CAPA procedure, “Messung, Analyse und Verbesserung (ver 1;01.03.2007),” section 8.2.2, requirement to report results of quality audit findings in the CAPA system and to document the quality audit finding on form 8-D-Report has not been implemented. For example, your firm did not include corrective and preventive actions relating to incomplete supplier certification records in the CAPA system. Your firm did not include corrective actions addressing equipment calibration records in your firm's electronic data management system. Your firm did not include corrective actions related to production routers not being completed at the time of production and did not indicate if this activity was examined for effectiveness.
 
c) The CAPA procedure, “Messung, Analyse und Verbesserung (ver 1;01.03.2007),” includes process improvements as a CAPA input; however, corrective actions addressing processes are not documented in the CAPA system. For example, (b)(4) were identified as processes that had not been validated in accordance with VA-142-03 Validation Master Plan for Process Validation (ver 1;16.01.2012). The corrective action is in process; however, there is no documentation that this corrective action is captured in the CAPA system.
 
d) The CAPA procedure, Messung, Analyse und Verbesserung (ver 1;01.03.2007), does not include the requirement that corrective and preventive actions, such as investigations and rework performed, include assessment of adverse effect on the finished device. For example, the four Form 8-D reports listed below in Observation 2 regarding (b)(4), do not document that the rework or other corrective action did not have an adverse effect on the finished device.
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate. Your firm will replace its CAPA procedure, Messung, Analyse und Verbesserung,with three new procedures:  (i) VA-Analyse, (ii) VA-Corrective and Preventive Action and (iii) VA-Fehlermanagement (Handling of Nonconformities). Your firm is revising its Form 8-D report, which is used to document corrective and preventive actions, to create additional tools, and to record and document analysis of quality data trends. Your firm plans to complete restructuring of its CAPA system by July 25, 2012, and plans to submit its progress to FDA on a periodic basis. 

However, your firm did not address the specific deficiencies regarding capturing and updating the supplier certification records, the equipment calibration records, and the “router” production records in the CAPA system.  Nor did your firm review its rework records and assess the adverse effect of rework on the finished device. Your response also did not address the specific deficiencies regarding process improvements such as (b)(4) processes.

 
2. Failure to adequately document all activities required under Corrective and Preventive Action, and their results, as required by 21 CFR 820.100(b). Review of five CAPA Form 8-D reports (amended in the Establishment Inspection Report (EIR)), out of eleven CAPA Form 8-D reports, disclosed that the documentation of correction and preventative actions was incomplete. For example:
 
a) The Form 8-D report entitled, “10 November 2011,” (b)(4), does not address the type of rework performed or document that the rework does not have an adverse effect on the finished device.
 
b) The Form 8-D report entitled, “02 November 2011,” regarding the investigation for (b)(4), did not include review of the production record for the finished device or the (b)(4) component.  
 
c) The Form 8-D report entitled, “20 October 2011,” regarding your firm’s investigation (b)(4) did not include documentation that the production record was reviewed.   
 
d) The Form 8-D report entitled, “11 October 2011,” regarding your firm’s investigation, identified the root cause for shipping the wrong product as human error.  However, this is not documented on the report. Improvement of the stocking number system was identified as the preventive action. The report is signed, but it does not indicate if this action has been completed.
 
e) The Form 8-D report entitled, “30 May 2011,” states that the corrective action of employee retraining was conducted on July 20, 2011. The CAPA report documents that this corrective action was completed on July 08, 2011, which is 12 days prior to when the corrective action occurred.
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate because the responses do not specifically address the deficiency cited. Instead, your firm explains that it previously used its customer complaint forms as allowed by its CAPA system. In the written response, your firm informed FDA that it plans to completely restructure its CAPA system procedure, which will require your firm to use its own complaint forms, and that it will include a review of the production record when investigating a nonconformity. The restructured procedure will also require your firm’s formally designated unit to review the form 8-D report in detail before finalizing the CAPA in order to ensure that all steps have been documented sufficiently and that all data is correct. Your firm plans to completely restructure its CAPA system procedure by July 25, 2012.
 
3. 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, the procedures for handling complaints, “(b)(4)(ver 1;01.03.2007)” and “(b)(4)(ver 1;01.03.2007),” do not address processing all complaints in a uniform manner. Your firm did not use Form 8‑D to document all complaints as required per your procedure.   
 
The adequacy of your firm’s responses dated February 07, 2012, and February 24, 2012, cannot be determined at this time. Your firm does not process complaints uniformly. If your firm receives complaints from its contract firms, it uses the contract firm’s complaint forms instead of its own Form 8-D report to process the complaint.  Your firm has promised to resolve this deficiency in the new CAPA procedure, “(b)(4),” and in the revised Form 8-D report.  This was to be implemented by May 13, 2012.
 
4. Failure to adequately 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 making the decision not to investigate, as required by 21 CFR 820.198(b). For example, the procedures for handling complaints, “(b)(4)(ver 1;01.03.2007)” and “(b)(4)(ver 1;01.03.2007),” do not require that complaints are investigated or require documentation when no investigation is conducted and the name of the individual responsible for making that decision.
 
The adequacy of your firm’s responses dated February 07, 2012, and February 24, 2012, cannot be determined at this time. Your firm has promised to include requirements for this deficiency in the new CAPA procedure, “(b)(4),” and in the revised Form 8-D report for all complaints. This was to be implemented by May 13, 2012.
 
5. Failure to adequately maintain a record of the complaint investigation by the formally designated unit, as required by 21 CFR 820.198(e). For example, the procedures for handling complaints “(b)(4)(ver 1;01.03.2007)” and “(b)(4)(ver 1;01.03.2007)” requires that your firm maintain record of all complaints received. But your firm used a customer’s complaint form instead of your firm’s Form 8-D. As a result, your firm’s record of the complaint investigation was incomplete. 
 
The adequacy of your firm’s responses dated February 07, 2012, and February 24, 2012, cannot be determined at this time.  Your firm has promised to include requirements for this deficiency in the new CAPA procedure, “(b)(4),” and on the revised Form 8-D report to include all complaints. This was to be implemented by May 13, 2012.
 
6. Failure to establish and maintain procedures for rework, to include retesting and reevaluation, of non-conforming product after rework to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). For example, the rework procedure, “(b)(4)(ver 01),” does not require a determination of any adverse effects from rework on the product. (b)(4). Additionally, records of rework occurring before January 2012 are not maintained. 
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate because the responses do not specifically address the deficiency cited. Your firm has promised to develop a new procedure to address rework, which will include the requirement to open a Form 8-D report for Products/processes to be reworked, the requirement to determine the adverse effect of rework on devices manufactured, and to document this determination on the Form 8-D report. Your firm stated that it would create a new procedure, “(b)(4),” by April 30, 2012, to provide the tools necessary for capturing quality data, including reworks, and for ensuring that quality data is analyzed adequately. In the interim period, your firm notes that it has confirmed that all required elements for device history records (DHR) exist and that they are maintained at your firm.
 
7. Failure to validate computer software for its intended use according to an established protocol, when computers or automated data processing systems are used as part of production or a quality system, according to established procedure, as required by 21 CFR 820.70(i). For example, there are no procedures that describe the qualification and maintenance of the Majesty Enterprise Resource Planning (ERP) software for production planning and maintenance of quality records. There are no software verification and validation requirements defined in your firm's procedures, and there are no records documenting that the Majesty system is validated or meets user needs and intended uses. The Majesty ERP software was updated to version 28.6 on approximately December 21, 2011, by the vendor; however, the review and approval of the software verification report was not approved until January 26, 2012. There are no procedures or documents that describe changes and version updates to the Majesty ERP system. There are no records that document the installation and first use date of version 28.2 in May 2011. There are no documents that define the system’s features and functions, operating environment, or hardware requirements.
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate. Your firm does not state if there are other software programs in use or if your firm plans to verify and validate other software programs. Your firm has promised to develop a new software verification and validation procedure and validate Majesty ERP software for its intended uses by April 13, 2012.
 
8. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, a review of your firm’s Quality Manual and other procedures disclosed that there were no references or procedures addressing equipment qualification and validation requirements. When the investigator asked your firm for an explanation, your firm confirmed that it does not have these requirements in its Quality Manual procedure or perform equipment qualification or validation of its in-house equipment or processes.
 
This observation was not cited on the FDA Form 483. During the inspection, the investigator discussed this observation with your firm and your firm promised to correct it. (b)(4). Your firm’s responses dated February 07, 2012, and February 24, 2012, did not address the creation of a new procedure or the status of the two process qualifications.
 
9. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:
 
a) The procedure, “(b)(4)(rev 1;20.01.12),” which addresses vendor selection qualification and requalification of suppliers, has not been not implemented.  There is no documentation that (b)(4), the supplier of Majesty software, was qualified or re‑qualified as a supplier. Your firm has been purchasing software from this vendor since 1996.
 
b) The requirements to requalify vendors in the purchasing procedure, “(b)(4)(rev 1;20.01.12),” are based on the percentage of products received by your firm from the vendor. The (b)(4) threshold required by your firm to re-qualify vendors is not based on the vendor’s ability to meet specified requirements, including quality requirements. In addition, the criticality of the purchased product or service is not evaluated for determining the needs to requalify suppliers.
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate. Your firm’s responses do not specifically address the deficiency cited and do not provide copies of revised procedures. Your firm has promised to revise its procedure and to develop a new procedure for supplier re-validation by April 13, 2012. Your firm also plans to re-evaluate suppliers upon completion of its new procedure. In the interim, your firm plans to review records to ensure that all suppliers of products and services have been captured in the system.
 
10. Failure to establish and maintain adequate procedures to control all required documents, as required by 21 CFR 820.40. For example, your firm failed to implement approval of new procedures in its document control system. The (b)(4) procedure, which establishes the threshold level for evaluating suppliers, is a handwritten note. This approval procedure is not specified in your firm's document control procedures.
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate. Your firm has promised to revise and replace this procedure with a new procedure by February 29, 2012, but this has not been completed yet.  In addition, your firm states that, in order to correct the root cause of this observation, your firm will review and revise its complete quality manual.  This was to have been implemented by April 13, 2012.
 
11. Failure to maintain adequate device master records (DMRs) that include or refer to the location of the production process specifications, including the appropriate equipment specifications, production methods, production procedures, and production environment specifications, as required by 21 CFR 820.181(b). For example, the device master record, “(b)(4)(ver 1;18.11.2010),” for endoplastic devices does not clearly reference the production process specifications. Your firm’s reference to the production instructions states that the "Production router/Drawings” are “Filed in IT/ filed in customer folder." 
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate. Your firm has promised to develop a new procedure to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.181, as applicable to the activities carried out by your firm’s contract manufacturer, by April 30, 2012. However, your firm’s response does not address the specific DMR for the device endoplastic devices cited.
 
12. Failure to establish and maintain DHRs to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR, as required by 21 CFR 820.184. For example, there are no procedures that describe the documentation required in the production routers.
 
The adequacy of your firm’s responses dated February 07, 2012, and February 24, 2012, cannot be determined at this time. Your firm has promised to develop a new procedure to ensure that each DHR is prepared and approved in accordance with the requirements of 21 CFR 820.184, as applicable to the activities carried out by its contract manufacturer, by April 30, 2012. In the interim period, your firm states that it has confirmed that all required elements for the DHR exist and are maintained at your firm. However, your firm’s response does not address the specific deficiency cited because your firm did not provide a copy of the production router document.
 
13. Failure to establish procedures adequate for identifying training needs and for ensuring that all personnel are trained to perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, the training procedure, “(b)(4)(ver 1;01.03.2007),” does not require production and quality personnel to be made aware of device defects that occur from improper performance of their job performance. 
 
Your firm’s responses dated February 07, 2012, and February 24, 2012, are not adequate. Your firm does not indicate if it would review training records of production and quality personnel to ensure that they were made aware of device defects as a correction. Your firm has promised to revise its current procedure by May 21, 2012, to include a requirement for production and quality personnel to be made aware of device defects that may occur from the improper performance of their assigned responsibilities. Your firm’s response states that it will immediately implement training with regard to the changes and revisions required for your firm’s corrective action, but there is no evidence of employee training in the responses.
 
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 #303918 when replyingIf you have any questions about the contents of this letter, please contact: LaShanda Long at 301-796-5770 or 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, 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
 
 
 
Cc: U.S. Agent:
      Business Support International
      271 Waldroup Road
      Hot Springs, NC 28743