Inspections, Compliance, Enforcement, and Criminal Investigations

Helica Instruments, Ltd. 5/13/16

  

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
MAY 13, 2016
 
VIA UNITED PARCEL SERVICE
 
Maurice Howieson
Chief Executive Officer
Helica Instruments, Ltd.
102 Kingsknowe Road, North Longstone
Edinburgh EH14 2DG
United Kingdom
 
Dear Mr. Howieson:
 
During an inspection of your firm, located in Edinburgh, United Kingdom,on November 9, 2015, through November 11, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrosurgical cutting and coagulation device and accessories, including the Helica Thermal Coagulator.  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 your response, dated November 25, 2015, 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 to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example:
 
a.  Your firm’s Nonconforming Product procedure does not adequately address: 
 
i.  The identification, documentation, evaluation, segregation, and disposition of nonconforming product;
 
ii.  The evaluation of nonconformance including a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance;
 
iii.  The review and disposition process;
 
iv.  Documentation of the disposition of nonconforming product;
 
v.  Documentation of rework and reevaluation activities including a determination of whether there has been any adverse effect from rework upon the product;
 
vi.  Documentation of rework and reevaluation activities in the device history record (DHR);
 
vii.  Ensuring that the procedures for the rework of nonconforming product includes retesting and reevaluation of the nonconforming product after rework to ensure the product meets its current approved specifications; and
 
viii.  The documentation of rework and reevaluation activities including a determination of any adverse effect from the rework upon the product in the DHR.
 
b.  Your firm failed to adequately evaluate and document the disposition, investigation and rework activities related to the following nonconforming product reports (NCR): NCR 205, NCR 209, NCR 210, NCR 217, and NCR 219.  
  
We reviewed your firm’s response and conclude that it is not adequate.  Your firm states that it will modify its nonconforming product procedure to include the requirements of 21 CFR 820.90. However, the response did not evaluate and document the disposition, investigation, and rework activities related to the identified nonconformities. In addition, your response did not describe if reviews of other NCRs will be performed, to determine if these were properly handled, once the revised nonconforming product procedure is implemented.
 
2.    Failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states it will establish a procedure for receiving, reviewing, and evaluating complaints by a formal designated unit, by June 30, 2016, as part of its overall corrective action plan. However, your firm’s response did not include an evaluation of previous NCRs, to determine if there were any NCRs related to complaints or MDR events.
 
3.    Failure to establish and maintain 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 has no written design change procedure. 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that it will establish a design change procedure by June 30, 2016, as part of its overall corrective action plan. However, your firm has not performed a risk analysis to determine the impact that a lack of identification, documentation, validation or verification, review, and approval of design changes has on marketed product.         
 
4.    Failure to establish and maintain 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 has no written procedures for design transfer.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that it will establish a design transfer procedure by June 30, 2016, as part of its overall corrective action plan. However, your firm’s response does not include a risk analysis of past design transfer activities to determine if these activities were properly performed, and to take corrective action where appropriate.
 
5.    Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example:
 
a.  Your firm’s “Design and Development Planning” procedure does not ensure that:
 
i.  Validation is performed on initial production units, lots, or batches or their equivalents;
 
ii.  Testing of production units are conducted under actual or simulated use conditions;
 
iii.  The design validation includes risk analysis; and,
 
iv.  The results of the design validation including identification of the design, methods, the date, and the individuals performing the validation are documented in the design history file (DHF).
 
b.  The validation protocol and related report including supporting test results and raw data for Helica TC, LT Probe, and LTC Probe were not documented in the related technical file or DHF, and could not be located by your firm.
 
c.  Electromagnetic Compatibility (EMC) testing for Helica TC with LTC probes was not documented in the DHF, and could not be located by your firm.
 
d.  The Helica TC Packaging validation protocol and supporting test results were not documented in the DHF, and could not be located by your firm.
 
e.  The shelf life testing in support of the label claim of two years Expiry Date for sterilized packaged LT and LTC Probes was not adequately documented. The only document included in the technical file was a Certificate of EP Sterility Testing for LT Probes, provided by the contract sterilizer, dated October 2, 2006.  No shelf life testing for the LTC Probes was performed.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that it will revise its “Design and Development Planning” procedure to conform to 21 CFR 820.30(g). Your firm states that it will establish a new packaging validation protocol, and perform EMC testing on the Helica TC, LT and LTC probes.  Shelf life testing will be reviewed and documented for the LT and LTC probes. Also, your firm will maintain the validation protocol and associated reports in the DHF for the Helica TC and probes, including test results and raw data. 
 
However, your firm’s response did not indicate it will evaluate the previous design to determine if devices previously distributed pose unmitigated risks and whether action is necessary to mitigate those risks.
 
6.    Failure establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f). For example,
 
a.  Your firm’s “Design and Development Planning” procedure does not ensure that the results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification are documented in the DHF.
 
b.  The design verification protocols and reports, including identification of the design, methods, the date, and the individuals performing the verification, including supporting test data, for Helica TC, LT Probe and LTC Probe were not documented in the related technical file (DHF) and could not be located by your firm.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states that a design verification procedure will be established. The “Design and Development Planning” procedure will be reviewed to ensure that the results of the design verification including identification of the design, methods, the date, and the individuals performing the verification are documented in the DHF. 
 
However, your firm’s response does not include a risk analysis of devices previously distributed and actions necessary due to lack of design verification.
 
7.    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’s design development, as required by 21 CFR 820.30(e). For example:
 
a.  Your firm’s Design and Development Planning procedure does not adequately address that: 
 
i.  Formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development;
 
ii.  Participants at each design review include representatives of all functions concerned with the design stage being reviewed and individuals who do not have direct responsibility for the design stage being reviewed, as well as any specialists needed;
 
iii.  The results of a design review, including identification of the design, the date, and the individuals performing the review, are documented in the DHF.
 
b.  The design review results, including identification of the design, the date, and the individuals performing the review, for the Helica TC, LT Probe, and LTC Probe were not documented in the related technical file or DHF, and could not be located by your firm.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states a design review procedure will be established. Your firm’s “Design and Development Planning” procedure will be reviewed to ensure that it conforms to 21 CFR 820.30(e).
 
Additionally, your firm’s response states that it is seeking an alternative main supplier for the manufacture of the Helica TC and probes. Your firm plans to perform a full design review and upgrade of the product as part of the supplier change. Your firm will incorporate its corrective actions and generate data and results that will be recorded in the DHF.
 
However, your firm’s response does not include a risk analysis of devices distributed prior to their design reviews, and corrective actions where appropriate.
 
8.    Failure to establish and maintain adequate 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 and Development Planning” procedure does not ensure that:
 
i.    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;
 
ii.    The procedure includes a mechanism for addressing incomplete, ambiguous or conflicting requirements;
 
iii.    Input requirements are reviewed and approved by designated individual(s) including the date and signature of the individual(s);
 
iv.    The related records are maintained in the related design history file.
 
b.  The design requirement determination and related activities including design input review and approval for Helica TC, LT Probe and LTC Probe were not documented in the related technical file (DHF) and could not be located by your firm.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states a design input procedure will be established. Your firm’s “Design and Development Planning” procedure will be reviewed to ensure that it conforms to 21 CFR 820.30(c).
 
However, your firm’s response does not include a risk analysis of devices previously distributed and actions necessary due to lack of design inputs.
 
9.    Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, your firm does not have a written procedure for finished device acceptance and release.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states it will establish a finished device acceptance procedure by June 30, 2016, as part of its overall corrective action plan. However, your firm’s response fails to include a risk analysis related to distributed products to determine potential risks or actions posed by the lack of finished device acceptance activities.
 
10.    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.  Your firm’s Purchasing procedure does not ensure that:
 
i.    The requirements that must be met by supplier, contractors, and consultants are established and maintained;
 
ii.    Potential suppliers, contractors, and consultants are evaluated and selected based on their ability to meet specified requirements;
 
iii.    The evaluation of potential suppliers, contractors, and consultants is documented;
 
iv.    The type and extent of control over the product, services, suppliers, contractors, and consultants is defined;
 
v.    Records of acceptable suppliers, contractors, and consultants are established and maintained;
 
vi.    Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and services are established, maintained, and approved; and
 
vii.    Where possible, an agreement is documented that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service provided.
 
b.  The approved supplier list does not include the following suppliers, service providers and consultants currently used by your firm:
 
i.  (b)(4)  
 
ii.  (b)(4) 
 
iii.  (b)(4) 
 
iv.  (b)(4) 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states it will establish a purchasing control procedure in conformance to 21 CFR 820.50, and update your approved supplier list where appropriate. However, your firm’s response does include an evaluation of records of previously received product to determine if the lack of supplier controls led to acceptance of nonconforming product.
 
11.    Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, the procedures “Corrective Action,” (b)(4), and “Preventive Action,” (b)(4), do not address the following:
 
a.  Analysis of sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems employing appropriate statistical methodology where necessary to detect recurring quality problems; and
 
b.  Verification or validation of the corrective and preventive action to ensure that such action does not adversely affect the finished device.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response states its “Corrective Action” and “Preventive Action” procedures will be reviewed and revised to correct the listed violations. However, your firm’s response does not include a plan to review existing CAPA records to determine if there are actions that were not verified or validated and identifying actions necessary to resolve those situations.
 
Our inspection also revealed that the Electrosurgical cutting and coagulation device and accessories are 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:
 
12.    Failure to develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, a document titled “Medical Device Vigilance System,” (b)(4), does not contain information indicating that it is an MDR procedure created in accordance with the requirements in 21 CFR 803.17.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm provided an action plan to rectify the observations in the FDA. Without evidence of implementation, which includes a copy of your firm’s MDR procedure, we cannot make a determination as to the adequacy of your firm’s response.
 
Our inspection also revealed that the Helica Thermal Coagulator is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do 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 (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).  The Helica Thermal Coagulator is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii).
 
Specifically, the Helica Thermal Coagulator was cleared under 510(k) # K972267 with the following indication: “a helium gas electrosurgical coagulator for use in all soft tissue surgery—laparoscopic, endoscopic and open.”  However, your firm’s promotion of the Helica Thermal Coagulator provides evidence that the device is intended for the treatment of endometriosis, which would be a major change or modification to its intended use, for which you lack clearance or approval.. For example, your website (http://www.helica.co.uk/helica-gynaecology.html) explains how the Helica Thermal Coagulator may be used in the treatment of endometriosis, including: 
  • The Helica Thermal Coagulator “allows the endometrioses to be treated at the same time as the laparoscopy is being performed.”
  • “The Helica T.C. destroys endometriosis by using a process called fulguration.”
  • “The Helica T.C. allows the Gynaecologist to be very accurate in treating the endometrioses and, when working close to reproductive organs, this reduces the risk of causing future furtility [sic] problems.”
  • “The Helica TC can be easily used at the time of the laparoscopy and can in most cases where endometriosis is present, give pain relief and increase the chances of pregnancy.”
The indication for treatment of endometriosis falls outside of the Helica Thermal Coagulator’s cleared indications and constitutes a major change or modification to the device’s intended use. Additionally, during the review of K972267, you submitted indications for the treatment of endometriosis. This indication was not included in the clearance for Helica Thermal Coagulator because you did not provide sufficient data to support that specific claim in your 510(k) submission.
 
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 C.F.R. 807.81(b).  The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
The FDA requests that your firm immediately cease activities that result in the misbranding or adulteration of the Helica Thermal Coagulator, such as the commercial distribution of the devices for the use discussed above.
 
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 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993.  Refer to CMS case # 491658 when replying. If you have any questions about the contents of this letter, please contact Daniel Walter, 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/
Robin W. Newman
Office Director
Office of Compliance
Center for Devices and Radiological Health
                                   
                         
Cc:
John B. Webb
U.S. Agent
Helica Instruments, Inc.
20 N Orange Ave., Suite 600
Orlando, FL 32801

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