Gaeltec Devices LTD - 554344 - 07/02/2018

JULY 2, 2018

WARNING LETTER
VIA UNITED PARCEL SERVICE

Derek L. Apps
General Manager
GAELTEC DEVICES LTD
Glendale Road
Dunvegan, IV55 8GU
United Kingdom

Dear Mr. Apps:

During an inspection of your firm located in Dunvegan, United Kingdom on December 4, 2017, through December 7, 2017, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Catheter Tip Pressure Transducers. 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. These violations include, but are not limited to, the following:

1.    Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example, your firm has not established process validation procedures. Additionally, in 2014, your firm added the “(b)(4)” as a new method of sterilization for the pressure transducers and did not validate this sterilization method.

2.    Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). Specifically, your firm’s procedure "CORRECTIVE ACTIONS FOR QMS PROCEDURE (b)(4) (dated November 8, 2017) and (b)(4) (dated March 21, 2012) did not include the following requirements:

a. Verification of effectiveness of corrective actions. For example, a review of the following CAPAs revealed your firm has not performed CAPA effectiveness verification.
i. CAPA number 154 initiated on July 20, 2017, for absence of calibration procedures for oscilloscopes. As part of the corrective action, your firm created a calibration procedure and added this procedure to your quality system. The CAPA was closed on July 20, 2017 without verifying the effectiveness of the corrective action.
ii. CAPA number 149 initiated on December 8, 2016, for the silicon tube used in the production of Gaeltec catheters being labeled “in vitro use only.” As part of the preventive action, your firm stated that the materials and suppliers would be routinely checked for continuing conformity to quality standard. The CAPA was closed on December 8, 2016 without verifying effectiveness of the preventive action

b. Instructions describing how preventive actions initiated by your firm are handled.

3.    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). Specifically, your firm’s procedures "CUSTOMER COMPLAINTS (b)(4)," issue 3, dated July 29, 2011, and "VIGILANCE PROCEDURE (b)(4)" issue 7, dated December 12, 2014, and issue 8, dated November 7, 2017, do not ensure that customer complaints are adequately handled. For example:

a. Customer concerns outside of your firm's warranty period of one year are not being documented as complaints, and are instead being handled through your firm’s return system. For example, return number (b)(4), initiated on May 3, 2017, for "fatigue of wire between wire label sleeve and MC connector on Ch1 Red & Black and Ch2 Black," was not added to your firm’s customer complaint system.

b. Complaint numbers (b)(4)(noise noticed by customer) and (b)(4), (device not working) were initiated on October 24, 2016, and May 3, 2017, respectively. Your firm has not evaluated these complaint to determine if they represent events that should be reported to the FDA per Medical Device Reporting requirements (21 CFR 803.)

4.    Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g). For example, your firm failed to ensure that all equipment used in the manufacturing of the transducers is maintained per "CALIBRATION TEST & MEASURING EQUIPMENT (b)(4)," issue 2, dated March 16, 1998. For example, your firm’s ultrasonic cleaner used in the manufacturing process is not included on the maintenance schedule and has no maintenance records.

5.    Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained 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. For example, your firm’s procedure "PRODUCTION JOB ROUTING PROCEDURE (b)(4)," issue 4, dated December 12, 2016, does not ensure that all required information is maintained as part of its job cards [equivalent to DHRs]. Three out of three job cards reviewed did not include the primary identification label and labeling used for each production unit.

Our inspection also revealed that the Catheter Tip Pressure Transducers manufactured by your firmare 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). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of the firm’s intent to introduce the devices into commercial distribution, in that notice or other information respecting modifications to these devices was not provided to 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)(i). Specifically, your firm has modified the Catheter Tip Pressure Transducer, cleared under K801757, by making the following changes:

Addition of Sterrad sterilization method.
Changes in the catheter’s lumen dimension and materials from 2.2 mm diameter, silicone rubber material to 7 mm diameter with a 6 Fr 2 mm diameter Polytetrafluoroethylene (PTFE) tube.
K801757 is cleared for 1-4 sensors that will be placed along the length of the catheter; however, an addition of more than 4 sensors on the catheter per customer request is not included in the cleared 510(k).

These changes require a new 510(k) because they could significantly affect the safety or effectiveness of these devices. For example:

The change in sterilization method for your reusable device presents a risk of patient infection and the additional risk of cross-patient infection; and
The changes in the lumen size, materials, and number of sensors are modifications that render these devices significantly different from the previously cleared device in K801757 and, thus, introduce additional questions of safety and effectiveness.

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.

Given the serious nature of the violations of the Act, the Catheter Tip Pressure Transducersmanufactured by your firm 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 responses 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, PMAs 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 #554344 when replying. If you have any questions about the contents of this letter, please contact: LCDR Cesar Perez at (301) 796-5476.

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,
/S/
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and Radiological Health

CC:
US AGENT
Bill Sones
Medical Measurements Incorporated
56 Linden Street
Hackensack, NJ 07601

U.S. Food and Drug Administration

Gaeltec Devices LTD MARCS-CMS 554344 — July 02, 2018