Inspections, Compliance, Enforcement, and Criminal Investigations

Fehling Instruments GmbH & Co. KG 10/13/15

  

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
OCT 13, 2015
 
VIA UNITED PARCEL SERVICE
 
Ulrike Lindner
Chief Executive Officer
Fehling Instruments GmbH & Co. KG
Hanauer Landstrasse 7A
63791 Karlstein
GERMANY
 
DearMs. Lindner:
 
During an inspection of your firm located at Hanauer Landstrasse 7A, Karlstein, Germany, on June 15, 2015, through June 18, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures cardiac biopsy instruments, ronguers, bone punches, and scissor 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 a response from Ulrike Lindner, dated July 10, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm.  Your firm’s response, dated July 30, 2015, to the FDA 483 was not reviewed for compliance with 21 CFR Part 820, because it was not received within fifteen business days of issuance of the FDA 483. The response will 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 establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. For example:
 
a)  Your firm’s Corrective and Preventive Action (CAPA) procedures do not include requirements for:
 
i.  Analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary.
 
ii.  Verifying and validating corrective and preventive actions to ensure such actions are effective and do not adversely affect the finished devices.
 
iii.  Disseminating information related to quality problems and nonconforming product.
 
iv.  Ensuring submission of relevant information for management review.
 
v.  The documentation of all CAPA activities.
 
b)  Your firm’s CAPA records (b)(4) and CAPA (b)(4) were incomplete. CAPA M14-012 was initiated to address long repair times for devices. CAPA M14-002 was initiated to address unclear shipping and packaging work instructions. These CAPAs were closed without:
 
i.  Verifying or validating the corrective actions to ensure that such actions were effective and did not adversely affect the finished devices.
 
ii.  Disseminating information related to the quality problem to responsible personnel.
 
iii.  Documenting training at the time it was received.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that a retrospective review of CAPAs from January 2014 to June 2015 would be conducted to ensure compliance with the revised procedures.  However, your firm’s response did not address the results of the retrospective review, timeline for the remediation of CAPA files, and implementation and effectiveness verification of short-term action (b)(4). Your response did not include documentation of implementation of the revised procedures, such as training records and documentation.
 
2.    Failure to establish and maintain procedures for receiving, reviewing, and evaluation complaints by a formally designated unit, as required by 21 CFR 820.198. For example:
 
a)  Your firm’s complaint handling procedures do not include requirements to ensure that:
                                                                                     
i.  Oral complaints are documented upon receipt.
 
ii.  A formally designated unit receives, reviews, and evaluates complaints.
 
iii.  Complaints are processed in a uniform and timely manner.
 
iv.  Complaints are evaluated for MDR reportability.
 
v.  Complaints that meet the MDR reportability criteria are promptly reviewed, evaluated, and investigated by a designated individual, and maintained in a separate portion of the complaint files or otherwise clearly identified.
 
b)  Your firm’s complaint handling procedures do not include requirements which ensure that the records of investigation include:
 
i.  Whether the device was being used for treatment or diagnosis when the reported incidence occurred.
 
ii.  The date the complaint was received.
 
iii.  The name, address and phone number of the complainant.
 
iv.  The nature and details of the complaint.
 
v.  The dates and results of the investigation.
 
vi.  Any reply to the complainant.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that a retrospective review of complaints from January 2014 to June 2015 would be conducted to ensure compliance with the revised procedures. However, your response did not address the results of the retrospective review, timeline for the remediation of complaint files, implementation, and effectiveness verification of short-term action (b)(4). Your firm’s response did not address when personnel will be trained on your firm’s revised complaint handling, work instruction, and associated complaint form. Also, your firm has not provided documentation that demonstrates the implementation of your proposed actions.
 
3.    Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c). For example:
 
a)  Your firm’s design control procedures do not include requirements to ensure design input requirements are reviewed and approved by a designated individual.
 
b)  There was no documentation of the date and signature of the individuals approving the design input requirements for design project (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include a retrospective review of previous design input specifications to ensure review and approval was properly documented or missing, or if additional corrective action was required as a result. Further, your firm’s response did not address when personnel will be trained on your firm’s revised design control procedures, work instruction, and associated design input form. Also, your firm has not provided documentation that demonstrates the implementation of your proposed actions.
 
4.    Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example:
 
a)  Your firm’s design control procedures do not include requirements to ensure design verification results, including identification of the design, methods, date, and the individual(s) performing the verification, are adequately documented in the design history file (DHF).  
 
b)  There was no documentation of the design verification results, including identification of the design, methods, date, and the individual(s) performing the verification, for project (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include a retrospective review of design history files to ensure design verifications were properly documented or missing, or if additional corrective action was required as a result. Further, your firm’s response did not address when personnel will be trained on your firm’s revised design control procedures, work instruction, and associated design testing form. Also, your firm has not provided documentation that demonstrates the implementation of your proposed actions.
 
5.    Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example:
 
a)  Your firm’s design control procedures do not include requirements to ensure that:
                                                                                     
i.  Participants at each design stage being reviewed 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.
 
ii.  The results of a design review, including identification of the design, the date, and the individuals performing the review, are documented in the design history file (DHF).
 
b)    There was no documentation of the design review results, including identification of the design, the date, and the individuals performing the review for project (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response did not include a retrospective review of design history files to ensure design reviews were properly documented. Further, your response did not address when personnel will be trained on your firm’s revised design control procedures, work instruction, and associated design review form. Also, your firm has not provided documentation that demonstrates the implementation of your proposed actions.
 
6.    Failure to ensure that rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, are documented in the Device History Record (DHR), as required by 21 CFR 820.90(b)(2). For example:
 
a)  Your firm’s nonconforming product and rework procedure do not include requirements to ensure rework, including a determination of any adverse effect from the rework upon the product, is documented within the DHR.
 
b)  There was no documentation in the DHR for the Ceramo Tradition X unit requiring rework from (b)(4)
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s response indicated that your firm will initiate a CAPA to revise nonconforming product and rework procedures to meet the CFR requirements. However, your response did not include: the revised procedures; documentation of implementation, such as training records; and documentation of rework initiated and handled under the revised procedures. Further, your firm did not perform a retrospective review of rework records to ensure compliance with your firm’s revised procedures, and whether there was any adverse effect from rework on device quality and patient safety.
 
7.    Failure to establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, as required by 21 CFR 820.72(a). For example, your firm’s calibration procedures require that the (b)(4) calibrated every three years. However, the (b)(4) was not calibrated from May 2012, through May 2015.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response did not include a retrospective review of calibration records to ensure calibrations were conducted within timeframes; and assess whether there was any adverse effect on device quality for instruments that may have been used while out of calibration.
 
Our inspection also revealed that your firm’s bone punches are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Our inspection also revealed that the cardiac biopsy instrument devicesare 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 regarding 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. Significant deviations include, but are not limited to:
 
8.    Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing the firm’s MDR procedure titled “Number 4.3.1, ‘Market Surveillance; Incidents and Complaints Procedure,’” Revision 8, the following issues were noted:
 
a)  Your firm’s MDR procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
 
b)  Your firm’s MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example, there are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
 
c)  Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
 
i.  Instructions for how to obtain and complete the FDA 3500A form.
 
ii.  The procedure does not include FDA 3500A form and instruction links to the appropriate FDA websites. We recommend including the following links: 
iii.  The circumstances under which your firm must submit initial 30 days, supplemental or follow-up, and 5-day reports and the requirements for such reports.
 
iv.  Instructions for how your firm will submit all information reasonably known to it for each event.
 
d)  Your firm’s MDR procedure does not describe how it will address documentation and record-keeping requirements, including:
 
i.  Documentation of adverse event related information maintained as MDR event files.
 
ii.  Information that was evaluated to determine if an event was reportable.
 
iii.  Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
 
iv.  Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
We reviewed your firm’s response and conclude it is not adequate. Your firm submitted a revised MDR procedure, “Number 4.3.1, ‘Market Surveillance; Incidents and Complaints Procedure,’” Revision 9. The remaining deficiencies are as follows:
 
a)  Your firm’s revised MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “caused or contributed,” “malfunction,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead the firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
 
b)  Your firm’s revised MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following is not addressed:
 
i.  Although the procedure includes references to 30 day, 5 day reports, it does not specify calendar days and work days, respectively.
 
ii.  Instructions for how your firm will submit all information reasonably known to it for each event.
 
c)  Your firm’s MDR procedure does not describe how it will address documentation and record-keeping requirements, including:
 
i.  Documentation of adverse event related information maintained as MDR event files.
 
ii.  Information that was evaluated to determine if an event was reportable.
 
iii.  Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.
 
iv.  Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:  http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
 
Given the serious nature of the violations of the Act, bone punchesmanufactured by your firm and offered for sale without premarket clearance, are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
 
Also, 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. 
 
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 actions (which must address systemic problems) 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 Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #479523 when replying. If you have any questions about the contents of this letter, please contact LT David Dar, Acting Chief, Foreign Enforcement Branch, at feb@fda.hhs.gov (email) or +1(240)402-4020 (telephone).
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/
CAPT Sean M. Boyd, MPH, USPHS
Acting Director
Office of Compliance
Center for Devices and Radiological Health
 
Cc:
Peter Skott
U.S. Agent
Fehling Surgical Instr. Inc.
509 Broadstone Lane NW
Acworth, Georgia 30101

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