Futrex Incorporated 2/5/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive
Baltimore, MD 21201-2199
Telephone: (410) 779-5455
FAX: (410) 779-5705
RETURN RECEIPT REQUESTED
February 5, 2013
Ms. Carole R. Rosenthal, President
130 Western Maryland Parkway
Hagerstown, Maryland 21740
Dear Ms. Rosenthal:
During an inspection of your firm located in Hagerstown, MD, on October 22-23, and 26, 2012, and November 5, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the HealthGuard-15(HG-15) Blood Pressure and Body Fat Measurement System. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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 any function of the body.
Our inspection revealed that the HealthGuard-15 Blood Pressure and Body Fat Measurement System(HG-15) is 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/cdrh/devadvice/3122.html.
We reviewed your firm’s H-15Design History document dated November 15, 2012, which justifies your firm’s rationale that this product does not require the submission of a premarket notification under section 510(k). However, our review determined that the HG-15 device does require a section 510(k) submission.
Our inspection also revealed that your firm’s devices 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 respecting the device 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 violations include, but are not limited to, the following:
Failure to adequately develop, maintain, and implement written medical device reporting (MDR) procedures, as required by 21 CFR 803.17.
We reviewed your firm’s MDR procedure titled, “Futrex Complaint and Vigilance System, Procedure No. 1-068 Rev. C,” dated 9/17/2008, and conclude that it is not adequate. The procedure fails to meet the requirements of 21 CFR 803.17. The following issues were noted:
1. Procedure 1-068 does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to the MDR requirements. For example:
a. Procedure 1-068describes your firm’s process to identify, document, and report events to the European Union Competent Authority. It does not describe your firm’s process to identify complaints that may meet the requirements of reportability as an MDR.
b. There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 of the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions of the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
2. Procedure 1-068 does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. Instructions for how to obtain and complete the FDA 3500A form.
b. Circumstances under which an event must be submitted as a 30-calendar day or 5-day report.
c. How your firm will submit all information reasonably known to it for each event.
d. The circumstances under which your firm must submit initial, supplemental, or follow-up reports and the requirements for such reports.
e. Procedure 1-068,Page 5 of 6, Section 7.1, describes submission of initial reports to Competent Authorities in the country in which the incident occurred. The correct mailing address to send MDR reports to FDA is listed. However, there is an obsolete reference to faxing MDR reports to FDA, including an incorrect phone number. All references to faxing MDR reports to FDA should be removed from your firm’s MDR procedure.
f. Procedure 1-068 states on Page 4 of 6, Section 5.2: “For information on what to report and types of reports to submit to the FDA see Medical Device Reporting for Manufacturing.” This statement will not allow your firm to determine the types of reports or information to submit to FDA.
3. Procedure 1-068 does not describe how your firm will address documentation and record-keeping requirements, including:
a. Documentation of adverse event related information maintained as MDR event files;
b. Information that was evaluated to determine if an event was reportable;
c. 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; and
d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov
Additionally, we are in receipt of your response dated January 10, 2013. Your response addresses the Quality System Regulation observations identified on the FDA-483. You provided documentation of updated procedures that became effective November 2012 through January 2013, but did not share documentation of employee training on these revised procedures.
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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.
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, 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.
Your firm’s response should be sent to: U.S. Food and Drug Administration, Attention: Evelyn Bonnin, District Director, at 6000 Metro Drive, Suite 101, Baltimore, MD 21215. When replying, refer to the Unique Identification Number CMS #385318. If your firm has any questions about the contents of this letter, please contact CDR Rochelle B. Young, RPh, MSA, Compliance Officer at 410-779-5437 via telephone or 410-779-5703 via fax.
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, Form 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.
Baltimore District Office