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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Compumedics Germany Gmbh 8/1/12

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

 

WARNING LETTER
AUG 1, 2012 
 
VIA UNITED PARCEL SERVICE
 
Christoph Witte
General Manager
Compumedics Germany Gmbh
Josef Schüettuer – Straße 2
78224 Singen, Germany
 
Dear Mr. Witte:
 
During an inspection of your firm located in Singen, Germany, on March 19, 2012, through March 22, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II pulsed Doppler ultrasonic imaging diagnostic 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 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.  FDA received a response from you dated April 4, 2012, concerning the investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm, as well as a May 30, 2012, response was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. FDA addresses the April 4 response below, in relation to each of the noted violations.  These violations include, but are not limited to, the following:
 
1.    Failure to adequately ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that 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, (b)(4)
 
Validation ((b)(4)) rev(b)(4), dated (b)(4), states that (b)(4); however, (b)(4). Also, (b)(4), your firm did not perform (b)(4). Further, your firm failed to monitor and control process parameters for a validated process to ensure that the specified requirements are met, in that your firm did not have a procedure for monitoring parameters, including temperature, of the (b)(4).
 
Your firm’s response dated April 4, 2012, is not adequate. While the response describes the revised validation of the (b)(4). Additionally, while the response states that your firm implemented (b)(4).
 
2.    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 (b)(4) (KuV Correction and Improvement) procedure does not include requirements for:
 
a.    Appropriate statistical methodology where necessary to detect recurring quality problems;
b.    Investigating the cause of nonconformities relating to product, processes, and the quality system;
c.    Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device;
d.    Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
 
Specifically, with respect to Correction and Improvement Forms (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), and (b)(4), your firm failed to investigate the cause of nonconformities and verify or validate the corrective or preventive action to ensure that the action is effective.
 
Your firm’s response dated April 4, 2012, is not adequate. The response references a revised CAPA procedure; however, it was not included with the response. Additionally, your response states that previous CAPAs are to be retrospectively analyzed in correspondence to the new definitions regarding relevance of complaints. Your firm’s response failed to indicate whether the revised CAPA procedure will address the requirements of 21 CFR 820.100, verifying or validating the corrective and preventive action, to ensure that the action is effective and does not adversely affect the finished device.
 
3.    Failure to establish and maintain adequate procedures for validating the device design, such that the design validation is performed under defined operating conditions on initial production units, lots, batches, or their equivalents, and that the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, shall be documented in the Device History File (DHF), as required by 21 CFR 820.30(g). For example, your firm’s design control procedure, (b)(4), does not meet the requirements outline above.  For the (b)(4), the date and individuals performing the validation was not documented in the DHF. Also, in the validation summary table in (b)(4), a test is stated to have been performed at (b)(4); however, the supporting validation (b)(4) is not documented in the report.
 
Your firm’s response dated April 4, 2012, is not adequate. The response references a revised design controls procedure that was implemented; however, the document was not included with the response. While the response indicates corrections to be made, the proposed corrective action (e.g., revising the corresponding procedure such that this failure would not be repeated) is not included. Additionally, your firm’s response failed to indicate whether the design controls procedure will address the requirements of 21 CFR 820.30(g) found to be lacking in the inspection.
 
4.    Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device design development, as required by 21 CFR 820.30(e). Specifically, your firm’s design review procedure, Sections (b)(4) of (b)(4) does not ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. Also, your firm states that all design changes require design review prior to design transfer.  However, your firm failed to conduct a design review for design change project (b)(4), which was initiated to (b)(4).
 
The adequacy of the response dated April 4, 2012, cannot be determined at this time. Your firm’s response references a revised design controls procedure that was implemented but not provided for review (it is stated to be completed by (b)(4)), with information as to the individuals to be included in the review team. The response states that design change project (b)(4) will be documented according to the revised procedure, to the purpose if which is to ensure that all design changes are reviewed and evaluated; however no documentation was provided for this change to the project.
 
5.    Failure to adequately establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation, as required by 21 CFR 820.30(b). Specifically, your firm failed to ensure that plans are reviewed, updated, and approved as design and development evolves. For example, your firm’s design control procedure (b)(4). With respect to (b)(4).
 
The response dated April 4, 2012, is not adequate. The response states that (b)(4). While the response indicates corrections to be made, namely to ensure that plans are reviewed, updated, and approved as design and development evolves, a proposed corrective action (e.g., revising the corresponding procedure such that this failure would not be repeated) is not included. 
 
6.    Failure to review and evaluate all complaints to determine whether an investigation is necessary, and when no investigation is made, 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 21 CFR 820.198(b). Specifically, (b)(4), a complaint, was not documented as a complaint, no investigation was made, and there was no documentation of justification otherwise.
 
Your firm’s response dated April 4, 2012, is not adequate. The response references a revised complaint handling procedure; however, its specific revisions are not known since the document was not included with the response. Additionally, (b)(4). The response failed to indicate whether the revised complaint handling procedure will address the requirements of 21 CFR 820.198 found to be lacking in the inspection (e.g., reviewing and evaluating all complaints to determine whether an investigation is necessary).
 
7.    Failure to include in the record of investigation the name, address, and phone number of the complainant, as required by 21 CFR 820.198(e). For example, your firm’s complaint handling procedure, (b)(4), rev(b)(4), does not require that the record of investigation include the name, address, and phone number of the complainant.
 
Your firm’s response dated April 4, 2012, is not adequate. The response references a revised complaint handling procedure; however, its specific revisions are not known since the document was not included with the response. Additionally, the response states that your firm is (b)(4). Your firm’s response failed to indicate whether the revised complaint handling procedure will address the requirements of 21 CFR 820.198 found to be lacking in the inspection (e.g., requiring that the record of investigation include the name, address, and phone number of the complainant).
 
8.    Failure to adequately establish and maintain procedures to control all documents that are required by 21 CFR Part 820, as required by 21 CFR 820.40. For example:
 
a.    Your firm’s Document Controls procedure (b)(4), (b)(4) rev(b)(4), dated (b)(4), failed to ensure that change records include identification of affected documents and when the change becomes effective.
b.    Your firm’s Document Controls procedure requires that change records include a description of the change within the newly changed document. However, your firm’s Quality Manual, (b)(4), (b)(4) rev (b)(4), dated (b)(4), was revised and no description of the changes were recorded in the latest revision.
c.    Your firm’s Design Validation and Verification procedure, (b)(4), Rev (b)(4), is dated to be valid on (b)(4), which is prior to the document approval date of (b)(4).
 
The adequacy of the response dated April 4, 2012, cannot be determined at this time. Your firm’s response references a revised document controls procedure that was not provided (it is stated to be completed by (b)(4)), with requirements for the identification of affected documents. Your firm states that the (b)(4).” The response explains that the (b)(4).
 
9.    Failure to adequately maintain Device History Records (DHRs) to demonstrate that the device is manufactured in accordance with the Device Master Record and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184. Specifically, (b)(4). Your firm’s DHR for (b)(4).
 
Your firm’s response dated April 4, 2012, appears to be adequate. The response states that the failure noted was an (b)(4).
 
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 FDA’s 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 #327299 when replying. If you have any questions about the contents of this letter, please contact: William C. MacFarland, Director, Division of Enforcement B, via telephone at (301)796-5540, 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