Inspections, Compliance, Enforcement, and Criminal Investigations
TZ Medical Inc. 4/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788FAX: 425-483-4996
April 10, 2012
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 12-23
Thomas R. Tribou
Owner and Chairman of the Board
TZ Medical, Inc.
7272 SW Durham Road, Suite 800
Portland, Oregon 97224
Dear Mr. Tribou:
During an inspection of your firm located in Portland, Oregon, on August 22, 2011, through August 25, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the following hemostasis pads and band products: Neptune Pad, Neptune Comfort-Band, Comfort Band (these three products are referred to collectively as “Neptune Products”), Neptune Plus Pad, Neptune Dot Pad, Hemo, and Hemo II. 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.
During the inspection, FDA learned that your firm is marketing and promoting the Neptune Products in the United States without the required marketing clearance or approval, in violation of the Act. Specifically, the Neptune Products were cleared under K040208 with the following indications: “Neptune products are used to promote the rapid control of bleeding and hemostasis for wounds, the skin surface at arterial/vascular sites and in patients on anticoagulation therapy.” However, you are marketing the Neptune Products as anti-microbial barriers and making claims representing that the Neptune Pad has an effect at the femoral artery, when it only works to staunch bleeding at the actual catheter access site to the skin, both of which represent major changes in the intended use of the device. For example, your website, www.tzmedical.com, visited most recently on April 10, 2012, had the following claims:
- “TZ Medical, Inc. announced the additional claim of “Natural Anti-Microbial Barrier” to its Neptune family of topical hemostatic devices, which include the Neptune Pad, Neptune Disc, and Neptune Comfort Band. The claim of “Natural Anti-Microbial Barrier” is related to the natural characteristics of calcium alginate. Calcium alginate is the main component of the Neptune family of hemostatic products.”
- “Having a natural anti-microbial barrier is an effective deterrent to hospital acquired infections and should help our customers reduce their costs,” according to Thomas R. Tribou, President of TZ Medical, Inc. Additionally Mr. Tribou went on to say “Millions of Neptune products have been used safely on patients around the world without any concern of adverse antibody reactions. Hospitals and patients will now have additional benefits from using the all natural Neptune products.”
Product packaging and labels collected during the inspection also had claims to provide an anti-microbial barrier, in addition to the following claims:
- “Healing Power From The Sea”
- “The TZ Medical Neptune Pad is a natural product derived from seaweed to help facilitate hemostasis following femoral catheterization.”
The indication that a device provides an antimicrobial barrier implies that microorganisms are kept from the wound either by an impenetrable barrier or by the inclusion of a preservative in the device construction or formulation. Such a claim might cause a physician to not prescribe an antibiotic or be less cautious in the treatment of the patient resulting in an unacceptable risk to the safety of the patient.
Promotion of these devices for the claims listed above represents a major change or modification of their intended use under 21 CFR 807.81(a)(3)(ii). Because of these claims, the Neptune Products are 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 Neptune Products are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not submit to the FDA a notification respecting the changes to the intended use of the device, 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).
Neptune Plus Pad, Neptune Dot Pad, Hemo, and Hemo II
Additionally, during our inspection the investigator obtained product labeling and promotional brochures for the following hemostasis products: the Neptune Plus Pad, Neptune Dot Pad, Hemo, and Hemo II. A review of our records reveals that you did not obtain marketing approval or clearance before you began offering these devices for sale, which is a violation of the law. Specifically, the Neptune Plus Pad, Neptune Dot Pad, Hemo, and Hemo II are 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 Neptune Plus Pad, Neptune Dot Pad, Hemo, and Hemo II are 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 these 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) 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/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed. We also note that you make the same antimicrobial barrier and wound healing claims for these devices as described above.
Our inspection also revealed that your hemostasis pad 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. These violations include, but are not limited to, the following:
1. Failure to adequately develop, maintain and implement written MDR Procedures as required by 21 CFR Part 803.17(a). For example, the following failures were noted from your firm’s MDR Procedure:
Your firm’s procedure entitled Medical Device Reporting Procedure; Rev. 1.0, dated October 20, 2010, fails to establish a process that provides for:
a. Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. Specifically:
i. Your firm’s procedure includes definitions from 21 CFR Part 803.3, but omits “Caused or contributed.” The exclusion of this definition from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that meets the criteria for reporting under 21 CFR Part 803.50(a).
b. Timely submission of complete medical device reports. Specifically:
i. Your firm’s procedure references that the FDA Form 3500A should be completed “according to CDRH instructions.” However, your procedure does not reference how to gain access to the form.
ii. Your firm’s procedure does not reference the types of information that should be included on the FDA Form 3500A.
iii. Your firm’s procedure does not include the address identifying where the MDR reports should be submitted. The address to submit MDR reports is: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, Maryland 20847-3002.
In addition, your firm’s procedure includes references to baseline reports. Please note, baseline reports are no longer required and all references to a baseline report should be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
If your firm wishes to submit MDR reports via electronic submission it can follow the directions stated at the following URL: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
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.
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/or 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 awarding 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.
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.
Quality System Regulation Concerns
We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820):
1. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, your firm failed to adequately document and evaluate nonconforming product. For example, (b)(4) Hemo 1 devices with lot number A0701-H1 were documented as rejected and scrapped on April 5, 2011. The documentation lacked information on why the Hemo 1 devices were rejected and whether the nonconformance was evaluated (to include a determination of the need for an investigation of the nonconformance and notification of the persons or organizations responsible for the nonconformance).
We received a response from you on September 9, 2011, concerning our investigator’s observations noted on the Form FDA 483, that was issued to your firm at the conclusions of the inspection. With respect to the above observation, we conclude that your response is not adequate. Your firm stated that the lot of Hemo 1 devices cited met all specification requirements, but were rejected due to (b)(4). Your firm also states that it has implemented and provided a copy of Cosmetic Standard for Finished Parts Work Instruction, Rev 1.2, dated August 30, 2011. This work instruction has been updated to include visual examination for cosmetic defect of “(b)(4)” and rejection criteria for this cosmetic defect. However, your firm has not investigated why (b)(4), whether similarly packaged products (b)(4) or checked complaints to see if previous lots (b)(4).
2. Failure to establish and maintain procedures to ensure that device history records (DHR's) for each batch, lot, or unit are maintained, as required by 21 CFR 820.184. Specifically, DHRs for the Neptune and Neptune Plus hemostasis devices do not include or refer to the location of the date of manufacture of Neptune calcium alginate pads (e.g. (b)(4) Neptune pad devices, Lot Number 19450052(4), Release Date September 1, 2009; and (b)(4) Neptune Plus devices, Lot Number 19089463, Release date June 24, 2011).
Your firm’s response to this observation appears to be adequate. Your firm states that your Outsource Responsibility Assignment form requires your suppliers to maintain a device history file that would include the date of manufacture. To facilitate the review of manufacture dates, your firm has requested that all manufacturers supply a manufacture date that is traceable to specific runs or DHRs at its facility. Your firm will add this manufacture date to its DHR so that the product is traceable to the supplier's manufacture date, as well as the lot number and ship date.
Your firm’s response should be sent to Lisa M. Althar, Compliance Officer, Food and Drug Administration, 22201 23rd Drive Southeast, Bothell, Washington 98021. If you have any questions about the content of this letter please contact Ms. Althar at (425)483-4940.
Charles M. Breen