Merit Medical Ireland Ltd. 1/30/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
JAN 30, 2012
VIA UNITED PARCEL SERVICE
Vice President, European Operations
Merit Medical Ireland Ltd.
Parkmore Business Park West
Dear Mr. Butler:
During an inspection of your firm located in Galway, Ireland, on September 12, 2011, through September 15, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Laureate Hydrophilic Guidewires. 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 are intended to affect the structure or function of the body.
Our inspection and subsequent telephone and communication with your firm’s U.S. Agent (Stephanie Erskin) on December 14, 2011, and December 19, 2011, revealed that your firm modified the hydrophilic coating process for the Laureate Hydrophilic Guidewires. The modification to the hydrophilic coating process constitutes a significant change or modification under 21 CFR 807.81(a)(3)(i) in that the change or modification could significantly affect the safety or effectiveness of the devices. Therefore, the Laureate Hydrophilic Guidewires 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 devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices 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 as indicated in Title 21, Code of Federal Regulations (CFR), section 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
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 awarding of contracts.
Please notify this office in writing within fifteen business days from the date your firm receives this letter of the specific steps your firm has taken to correct the noted violations, as well as 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response to this letter 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 #236954 when replying. If your firm has any questions about the contents of this letter, please contact: Daniel Walter at 301-796-5587 (phone) or (301) 847-8138 (fax).
Finally, 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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health