Inspections, Compliance, Enforcement, and Criminal Investigations

Richard Wolf Medical Instruments Corp. 2/28/14

  

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

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

February 28, 2014
 
WARNING LETTER
 
CHI-4-14
 
 
VIA UPS SAVER                                                                
CORRECTED COPY 2
 
Mr. Siegfried Karst
Chief Operating Officer
Richard Wolf, GmbH
Pforzheimer Straße 32
75438 Knittlingen75438 Knittlingen
Germany
 
Dear Mr. Karst:
 
A United States Food and Drug Administration (FDA) investigator conducted an inspection of your firm, Richard Wolf Medical Instruments Corporation, located at 353 Corporate Woods Parkway in Vernon Hills, Illinois from March 25, 2013 through May 8, 2013. The investigator determined that Richard Wolf Medical Instruments Corporation. (hereafter referred to as “RWMIC”) operates as a manufacturer, repackager and initial distributor of flexible/rigid endoscopes (Class II), electrosurgical units and accessories (Class II) , and the Hulka fallopian clip applicator, a Class III sterile, implantable medical device. Under Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(h)], these products are defined as 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 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 manufacturer, processing, packing, or holding 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 written responses, dated May 28, 2013, June 25, 2013, July 19, 2013, and August 26, 2013 from Mr. Neils Schmidt, General Manager, and Mr. Ron Haselhorst, Quality Assurance / Regulatory Affairs Manager for RWMIC, concerning our investigator’s observations noted on the FDA-483, Inspectional Observations, which was issued to Mr. Schmidt on May 8, 2013. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Your firm has failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically,
 
a.    Your firm’s procedure, “Complaint and Medical Device Reporting Process”, Document # QA-004 (Revision U), specifies, “Any instrument returned to RWMIC that contains a defect or operates abnormally or has a condition never seen before will be evaluated as a complaint.” During the inspection, twelve (12) out of forty-five (45) records reviewed were not appropriately identified and processed as complaints as per QA-004. For example:
 
i.      Return Authorization (b)(4), dated 3/4/13, documented a service contract repair for a Viper Ureterscope that was being returned because “DEFLECTION IS SIDEWAYS”.
ii.      Return Authorization (b)(4), dated 3/14/13, documented routine maintenance for a Bariatric Debakey that was being returned because, “Not holding onto tissue”.
iii.      Return Authorization (b)(4), dated 3/26/13, documented a Trial and Evaluation Department repair for a Viper Ureterscope that was being returned because the tip looks wrong, according to the sales representative.
iv.      Return Authorization (b)(4), dated 3/29/13, documented a repair for Ureterscope that was being returned because, “HAD PICTURE – STOPPED WHEN USING STONE BASKET”. This problem took place during a surgical procedure. 
 
b.    Your firm did not follow procedure QA-004 in that the following complaints were determined to be non-MDR reportable; however, a risk analysis or documented rationale was not provided to make the determination that death or serious injury would not result if the device malfunction were to recur. For example:
 
i.      Complaint # (b)(6), date received 10/16/12, indicated that a doctor began to use a Cobra Flexible endoscope for the second time when a snap was heard and the deflection stopped working. The Medical Device Reporting Decision Tree form, Form (b)(4) for this complaint, dated 10/18/12, indicated that the device failed or malfunctioned while being used on a patient.
ii.      Complaint # (b)(6), date received 1/13/12, indicated a report that the Forceps Tenaculum, Lot # (b)(4), broke and there was a concern that the device may be mislabeled or the incorrect item. The Medical Device Reporting Decision Tree form, Form (b)(4) for this complaint, dated 1/13/12, indicated that the device failed or malfunctioned while being used on a patient.
 
c.    Your firm’s procedure, “Complaint and Medical Device Reporting Process”, Document # QA-004 (Revision U), has not been adequately established to ensure that complaints are forwarded to the manufacturer of the device in a timely manner to determine whether the complaint represents an event which is required to be reported to the FDA as an MDR. For example:
 
i.    Complaint # (b)(6), date received 4/6/11, indicated a report that the Trigger-Flex Bipolar System electrode, Lot # (b)(4) and Lot # (b)(4), split in half while in use, and the physician had to use three electrodes on one patient.   This complaint was forwarded to the manufacturer on 4/27/11.
ii.    Complaint # (b)(6), date received 11/22/11, indicated a report that seven Trigger-Flex Bipolar System electrodes, Lot # (b)(4) (3 electrodes) and Lot # (b)(4) (4 electrodes), all stopped working when in use during a medical procedure. This complaint was forwarded to the manufacturer on 12/13/11.
 
We have reviewed your responses for part (a) and have determined that the responses are inadequate in that no detail or rationale was provided in your firm’s “RA Report” to support your firm’s determination that the examples cited in the FDA observation were not complaints. Similarly, this report did not provide justification for your firm’s determination that four (4) of the twelve (12) referenced records should have been classified as a complaint for further investigation. Your firm’s responses also failed to include complaint investigations into these four records after this determination was made. In addition, corrective actions, such as the revision of QA-004 to improve the Routine Maintenance Decision Table and the revision or creation of a new service procedure, were not provided for FDA review.
 
With regard to your firm’s responses for part (b), the adequacy of the corrective actions cannot be determined at this time because the proposed revision to the QA-004 procedure to include information on patient risk was not provided for FDA review.
 
With regard to your firm’s responses for part (c), the adequacy of the corrective actions cannot be determined at this time because the new procedure, QA-063, “Complaint Handling for Products Distributed by Richard Wolf Medical Instruments Corporation (RWMIC)”, was not provided for FDA review. 
 
2.    Your firm failed to clearly define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(2). Specifically,
 
a.    Your firm’s procedure, PU-004, “Approved Vendor List – Vendor Evaluation and Control” (Revision J), and forms, “Supplier Evaluation Form (b)(4)” and “Audit Check List Form (b)(4)”, which are used as part of your firm’s supplier evaluation and control process, do not include detail or justification to describe how the designations, (b)(4)”, given to suppliers to determine the type and extent of control to be exercised over them, are determined. 
 
b.    Your firm’s procedure, PU-004, indicates, “annual reviews of all approved vendors with a risk level of (b)(4) will be completed by the Purchasing Department and Quality Assurance using Form (b)(4) Supplier Evaluation.”   This procedure does not; however, define the criteria for rating the suppliers as “(b)(4)” or how these designations will affect the extent of control to be exercised over suppliers, services, contractors, and consultants.
 
We have reviewed your responses regarding parts (a) and (b) and have determined that the adequacy of your proposed corrective actions cannot be determined at this time because although we acknowledge that your firm revised Form (b)(4), Supplier Evaluation, and included the revised form with your response, your firm did not provide your revised procedure, PU-004. Evaluation of your firm’s revised procedure, PU-004, is needed in order to determine how these designations are made and what the designations mean with respect to the type and extent of control that will be exercised over suppliers. In addition, your updated responses indicated that Form (b)(4), Audit Checklist, has been revised; however, this document was not included for FDA review.
 
3.    Your firm failed to adequately establish requirements that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm has not adequately established the requirements to be met by the following suppliers:
 
a.    Richard Wolf, GmbH (parent corporation): According to your firm’s procedure, QA-006, “Final Inspection” (Revision N), “Unless otherwise specified, Richard Wolf; GmbH products do not require inspection when material is finished and no additional processing is required. (Material is verified correct and delivered to appropriate stockroom)”. 
 
b.    Suppliers deemed approved suppliers by Richard Wolf, GmbH: According to your firm’s procedure, PU-004, “Approved Vendor List-Vendor Evaluation and Control” (Revision J), the suppliers that are deemed approved suppliers by Richard Wolf, GmbH (parent corporation) are automatically considered approved suppliers by Richard Wolf Medical Instruments Corporation. 
 
The following examples of non-conforming products are associated with complaints received for product supplied by the Richard Wolf parent corporation or one of its approved suppliers:
 
  • Your firm received complaint # (b)(6) on 1/9/13 for a “Footswitch not working properly”. This device is an accessory for the Wellwave system, a Trigger point shock wave therapy system and was listed as a newly purchased item in the complaint report. This device had been purchased from an approved supplier of the Richard Wolf parent corporation and entered into stock. The complaint investigation determined that the device was non-conforming in that a cold solder on the pin connector of the device was identified which caused the device to not fire.
  • Your firm received complaint # (b)(6) on or around 12/14/12 for a laser guide insert for continuous irrigation that was received by a customer because the item should have been modified by the Richard Wolf parent corporation to accommodate a (b)(4); however, it was determined, as the stock was received, that the modification had not been made.
 
The adequacy of your firm’s corrective actions regarding parts (a) and (b) cannot be determined at this time because the new procedure, PU-008, “RWGmhB Vendor Relationship” which was created to define the relationships, responsibilities, and process for vendor and product acceptance and monitoring was not included for FDA review. In addition, your firm’s review to determine what other procedures should be updated is not yet complete. 
 
You should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice.  These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. 
 
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.
 
Your response should be sent to: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 407796) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224 or via email at carrie.plucinski@fda.hhs.gov.
 
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.  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,
/S/
Scott J. MacIntire
District Director
 
 
cc:        VIA UPS NEXT DAY
 
Mr. Niels J. Schmidt
General Manager
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
 

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