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U.S. Department of Health and Human Services

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Enforcement Actions

Market Technologies Inc. DBA Dermavista 12/2/13

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
 
Telephone: (615) 366-7801
FAX:   (615) 366-7802

 

December 2, 2013
 
WARNING LETTER NO. 2014-NOL-04
  
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Thomas E. Jackson, President
Market Technologies Inc., dba Dermavista
12585 Old Highway 280
Chelsea, Alabama 35043-3011
 
Dear Mr. Jackson:
 
On April 25 and May 8 – 9, 2013, a United States Food and Drug Administration (FDA) investigator inspected your firm, located at 12585 Old Highway 280, Chelsea, Alabama.  The inspection determined your firm is operating as a Manufacturer and Initial Importer of Class I and Class II aesthetic medical devices. This inspection found your firm imports and distributes the Vascutouch, Contour Ultra, Stratapulse IPL, Starpress, SW Ultrasound Basic, SW Ultrasound RF, DiamondMedilift, and Jet Clear aesthetic medical devices.  Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 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 any function of the body.
 
Medical Device Reporting
 
Our inspection revealed your firm’s devices are misbranded under Section 502(t)(2) of the Act [21 USC 352(t)(2)] because 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 USC 360i] and Title 21, Code of Federal Regulation (21 CFR) Part 803 - Medical Device Reporting (MDR). Specifically, your firm failed to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
 
We reviewed your firm’s response, dated May 28, 2013, and conclude it is not adequate. Your firm developed an MDR procedure. After reviewing your firm’s MDR Procedure entitled, (b)(4), Date: 5/24/2013, the following deficiencies were noted:
 
1.    Your procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:

a.    There are no definitions of what your firm will consider to be a reportable event under 21 CFR 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 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1). The exclusion of these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
 
b.    Your procedure references 21 CFR 804. As of March 27, 2000, Part 804 was removed from Title 21 of the CFR; FDA moved the MDR requirements for importers and domestic distributors of medical devices from 21 CFR 804 to 21 CFR 803.  The Final Rule implementing the changes made to 21 CFR 803 was published on January 26, 2000 (please see: http://www.gpo.gov/fdsys/pkg/FR-2000-01-26/html/00-1785.htm). Therefore, your firm should remove any references to 21 CFR 804 from your MDR procedure.
 
Your procedure does not establish internal systems that provide for a standardized review process or procedure for determining when an event meets the criteria for reporting under 21 CFR 803.  Specifically, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 
2.    Your procedure 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 Form FDA 3500A.
 
b.    The circumstances under which your firm must submit initial, supplemental or follow-up reports and the requirements for such reports.
 
3.    Your procedure 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.
 
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 you may 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, you may contact the Reportability Review Team by email via: ReportabilityReviewTeam@fda.hhs.gov
 
Unapproved Devices
 
Additionally, the inspection and review of your firm’s product brochures and website, www.dermavista.com, revealed your firm is marketing the Contour Ultra, Vascutouch, Starpress, SW Ultrasound Basic, SW Ultrasound RF, and Diamond Medilift devices in the United States without appropriate marketing approval, which is in violation of the Act. 
 
Contour Ultra
 
FDA reviewed your firm’s website and product brochure and determined the Contour Ultra is adulterated under Section 501(f)(1)(B) of the Act [21 USC 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 USC 360e(a)] or an approved application for an investigational device exemption (IDE) under Section 520(g) of the Act [21 USC 360j(g)] for the device as described and marketed.  The Contour Ultra is also misbranded under Section 502(o) of the Act [21 USC 352(o)] because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution without prior submission of a premarket notification to FDA, as required by Section 510(k) of the Act [21 USC 360(k)] and 21 CFR 807.81(a)(1); and, this device is intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 890.5660, Electric Therapeutic Massager.
 
Devices classified under 21 CFR 890.5660,Electric Therapeutic Massager, are exempt from premarket notification unless they exceed exemption limitations found in 21 CFR 890.9(a).  However, there is evidence the Contour Ultrais intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660. Generic devices of this type are intendedfor relief of minor muscle aches and pains or temporarily relieve minor muscular pain and tension caused by fatigue or overexertion. However, your firm is marketing the Contour Ultra for different intended uses. Examples include:
 
  • Drainage
  • Improvement of blood and lymph microcirculation
  • Improves skin quality
  • Improves muscle tone in the face and neck
  • Stimulates facial and neck muscles
  • Activates cellular renewal
  • Eliminates toxins
  • Decongests skin
  • Visibly reduces wrinkles
 
Because there is evidence the Contour Ultra is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660, it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.
 
Vascutouch
 
During the inspection, the FDA collected and subsequently reviewed your firm’s product brochure and determined that the Vascutouch is adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)] because your firm does not have an approved application for PMA in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an IDE under Section 520(g) of the Act [21 USC 360j(g)] for the device as described and marketed.  The Vascutouch is also misbranded under Section 502(o) of the Act [21 USC 352(o)] because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution without submitting a premarket notification to FDA, as required by Section 510(k) of the Act [21 USC 360(k)] and 21 CFR 807.81(a)(1); and, this device, is intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 878.5350, Needle-type epilator.
 
Devices classified under 21 CFR 878.5350, Needle-type epilator, are exempt from premarket notification unless they exceed exemption limitations found in 21 CFR 878.9(a). However, there is evidence the Vascutouch is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.5350. Generic devices of this type are intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla.  The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only. However, your firm is marketing the Vascutouch for a different intended use, namely, for quick and easy removal of Telangiectasia, spider veins, Cherry Angiomas, and Vascular Blemishes. Because there is evidence the Vascutouch is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.5350, it exceeds the limitations described in 21 CFR 878.9(a) and is not exempt from premarket notification.
 
Starpress Pressotherapy (Starpress)
 
FDA reviewed your firm’s product brochure and determined the Starpress is adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)] because your firm does not have an approved application for PMA in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an IDE under Section 520(g) of the Act [21 USC 360j(g)] for the device as described and marketed. The Starpress is also misbranded under Section 502(o) of the Act [21 USC 352(o)] because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution without submitting a premarket notification to FDA, as required by Section 510(k) of the Act [21 USC 360(k)], and 21 CFR 807.81(a)(1); and, this device is intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 890.5660, Electric Therapeutic Massager.
 
Devices classified under 21 CFR 890.5660 are exempt from premarket notification unless they exceed the exemption limitations found in 21 CFR 890.9(a). However, there is evidence the Starpressis intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660. Generic devices of this type are intendedfor relief of minor muscle aches and pains or temporary relief of minor muscular pain and tension caused by fatigue or overexertion. However, your firm is marketing theStarpressfor a different intended use, namely,for applying pressure sequentially along the extremities and body for treating: 
 
  • Lymphedema and venous edema
  • Cellulite
  • Post-trauma and post-surgery edema
  • Inadequate return circulation
 
The technology and claims of the Starpress are consistent with that of a compressible limb sleeve, 21 CFR 870.5800, which is a class II device. Because there is evidence the Starpress is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5660,it exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.
 
SW Ultrasound Basic
 
FDA reviewed your firm’s product brochure and determined the SW Ultrasound Basic is adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)] because your firm does not have an approved application for PMA in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an IDE under Section 520(g) of the Act [21 USC 360j(g)] for the device as described and marketed. The device is also misbranded under Section 502(o) of the Act [21 USC 352(o)] because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA, as required by Section 510(k) of the Act [21 USC 360(k)] and 21 CFR 807.81(a)(3)(ii). 
 
Specifically, the SW Ultrasound Basic was cleared under K991613 for use in applying therapeutic deep heat for selected medical conditions such as, relief of pain, muscle spasms, and joint contractures.  However, your firm’s promotion of the device provides evidence the device is intended forreduction of localized adiposities, excess weight, and cellulite, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. 
 
Furthermore, the SW Ultrasound Basic you are distributing uses an ultrasound frequency of 28 kHz while the SW Ultrasound originally cleared under K991613 used ultrasound frequencies of 1 and 3 MHz. The use of this lowered ultrasound frequency represents a major modification requiring you to notify FDA of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act [21 USC 360(k)] and 21 CFR 807.81(a)(3)(i).
 
SW Ultrasound RF
 
FDA reviewed your firm’s product brochure and determined the SW Ultrasound RF is adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)] because your firm does not have an approved application for PMA in effect pursuant to Section 515(a) of the Act, [21 USC 360e(a)] or an approved application for an IDE under Section 520(g) of the Act [21 USC 360j(g)] for the device as described and marketed. The device is also misbranded under Section 502(o) the Act [21 USC 352(o)] because your firm did not notify FDA of your intent to introduce the device into commercial distribution in that a notice or other information respecting the modification to the device was not provided to the FDA, as required by Section 510(k) of the Act [21 USC 360(k)]. 
 
Specifically, the SW Ultrasound RF is promoted for the reduction of localized adiposities, excess weight, and cellulite, and to firm, tone, and increase circulation and lymphatic drainage. Furthermore, the SW Ultrasound RF uses a 2.8 MHz ultrasound frequency with the addition of an RF (6 MHz) frequency. Your firm’s device may be subject to PMA because it is being marketed as an ultrasonic diathermy device for uses as described in 21 CFR 890.5300(b). 
 
Diamond Medilift
 
FDA reviewed your firm’s product brochures and determined the Diamond Medilift  is adulterated under Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)] because your firm does not have an approved application for PMA in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an IDE under Section 520(g) of the Act, [21 USC 360j(g)] for the device as described and marketed. The device is also misbranded under Section 502(o) of the Act [21 USC 352(o)] because you did not notify FDA of your intent to introduce the device into commercial distribution, as required by Section 510(k) of the Act, [21 USC 360(k)].
 
Specifically, the Diamond Medilift is being promoted with the following indications, including but not limited to:
 
  • Treat the face and neck at the same time
  • 24K gold handpieces firm & tone face & body muscles
  • Lypolic wave form mobilizes body fat
  • Lymphatic decongestion to reduce cellulite & dimpling
 
Stratapulse IPL
 
FDA reviewed the Stratapulse IPL user’s manual you provided during the inspection and noted nonconformance with Section 501(f)(1)(B) of the Act [21 USC 351(f)(1)(B)] because your firm does not have an approved application for PMA in effect pursuant to Section 515(a) of the Act [21 USC 360e(a)] or an approved application for an IDE under Section 520(g) of the Act [21 USC 360j(g)] for the device as described and marketed. FDA has also noted nonconformance with Section 502(o) the Act [21 USC 352(o)] because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA, as required by Section 510(k) of the Act [21 USC 360(k)] and 21 CFR 807.81(a)(3)(ii). 
 
Specifically, the Stratapulse IPL was cleared under K090837 with the following indications for the treatment of the following dermatologic conditions, among others:
 
  • Permanent hair reduction – long-term stable reduction in number of hairs re-growing after a treatment regimen.
  • Treatment of:
o   Moderate inflammatory acne vulgaris
o   Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles)
o   Cutaneous lesions including scars
o   Benign cutaneous vascular lesions including port wine stains; hemangiomas; facial, truncal, and leg telangiectasias; erythema of rosacea; leg veins; and, venous malformations
 
However, your firm’s promotion of the device provides evidence it is also intended forskin rejuvenation and breast enlargement,which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval.
 
For a device requiring PMA, the notification required by Section 510(k) of the Act [21 USC 360(k)] is deemed satisfied when a PMA is pending before FDA [See 21 CFR 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.  FDA will evaluate the information you submit and decide whether your product may be legally marketed.
 
FDA requests youimmediately cease activities resulting in the misbranding or adulteration of the Contour Ultra, Vascutouch, Starpress, SW Ultrasound Basic, SW Ultrasound RF, Diamond Medilift, and Stratpulse IPL, such as the commercial distribution of the devices for the uses above.  
 
Quality System Regulation
 
FDA has also noted nonconformance with regards to Section 501(h) of the Act [21 USC 351(h)] which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR 820.  Our investigator’s observations were presented to you on Form FDA 483, Inspectional Observations, at the conclusion of our inspection on May 9, 2013. 
 
We received your firm’s response to the Form FDA 483 on May 28, 2013, and our evaluation of your response is discussed below. Violations revealed during the inspection include, but are not limited to, the following:
 
1.    You failed to establish procedures for corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example, your firm failed to establish procedures for the following requirements:
 
a.    Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems;
 
b.    Investigating the cause of nonconformities relating to product, processes, and the quality system;
 
c.    Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
 
d.    Verifying or validating the CAPA to ensure such action is effective and does not adversely affect the finished device;
 
e.    Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems;
 
f.    Ensuring information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and,
 
g.    Submitting relevant information on identified quality problems, as well as CAPAs, for management review.
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. Your “Corrective and Preventive Action” procedure appears adequate. However, page 5 of the procedure has a list of acronyms with no key.
 
2.    You failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Such procedures shall ensure complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA, per 21 CFR 803. Specifically, your firm has no standard operating procedures implemented to determine if the complaint received represents an MDR reportable event. You failed to implement a standard operating procedure to ensure:
 
a.       All complaints are processed in a uniform and timely manner;
 
b.      Oral complaints are documented upon receipt; and,
 
c.       Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA, as required by 21 CFR 803.  
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. After review of your procedure, there appears to be some correction needed.
 
The following list describes changes needed to this procedure:
 
  • The definition of an MDR is incomplete. The full definition of an MDR reportable event can be found in 21 CFR 803.3. Please revise your procedure to include the entire definition of an MDR reportable event. 
  • (b)(4) refers you to record all complaints on the (b)(4) Form (b)(4); however, the Form is actually numbered (b)(4).
  • (b)(4) indicates information will be recorded on the (b)(4) Form and referenced Form (b)(4), which is the (b)(4) Form, not the (b)(4) Form.
  • (b)(4) refers the reader to “(b)(4)” for the MDR procedure. However, in the documents you provided for review, the MDR procedure is entitled “(b)(4)” and indicates it is “(b)(4).” 
  • (b)(4) references Form “(b)(4)” for the “(b)(4).” We were unable to locate this form. 
  • (b)(4) indicates information will be recorded on the “(b)(4)” The “(b)(4)” provided for review is referenced as form “(b)(4).” (b)(4) on the (b)(4) Form reads “(b)(4)” 
 
3.    You failed to document and maintain acceptance activities as part of the Device History Record (DHR), as required by 21 CFR 820.80(e). These acceptance records shall include: 1) the acceptance activities performed; 2) the dates acceptance activities are performed; 3) the results; 4) the signature of the individual(s) conducting the acceptance activities; and, 5) where appropriate, the equipment used. These records shall be part of the DHR.
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. The procedure describes your evaluation of “(b)(4)” You are also required to evaluate finished devices as part of the DHR. We reviewed the “(b)(4)” form and noticed you listed (b)(4) devices; however, the form indicates evaluation of “(b)(4)
 
4.    You failed to implement procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. Specifically, your firm failed to establish purchasing control procedures to define the requirements for suppliers and contractors and evaluate their ability to meet specified requirements. Additionally, a record of acceptable suppliers has not been established and maintained. 
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. (b)(4) of your “(b)(4)” procedure indicates suppliers are sent a “(b)(4)” of their quality system. This form was not provided in this procedure. 
 
5.    You failed to establish procedures for quality audits and to conduct such audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, you do not have procedures addressing quality audits, nor do you have records documenting quality audits of your facility and suppliers. 
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. (b)(4) of your “(b)(4)” procedure indicates the official Certificate of Audit will be retained for a period of (b)(4) from date of issuance. However, 21 CFR 820.180 requires records of the Quality System to be retained for a period of time equivalent to the design and expected life of the device, but in no case less than two years from the date of release for commercial distribution by the manufacturer.
 
6.    You failed to ensure management with executive responsibility reviews the suitability of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of 21 CFR Part 820, as required by 21 CFR 820.20(c). For example, your firm failed to establish written management review procedures and conduct management reviews of the suitability and effectiveness of the quality system at defined intervals. Additionally, a management representative has not been appointed.
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. The procedure appears adequate; however, your response did not indicate the appointment of a management representative.
 
7.    You failed to establish, maintain, and document procedures for ensuring all personnel are trained to adequately perform their assigned responsibilities and for identifying training needs, as required by 21 CFR 820.25(b). For example, your firm failed to document training activities for Market Technologies, Inc. employees involved in complaint and MDR handling, quality assurance, or other assigned responsibilities. In addition, procedures for identifying training needs were not established, documented, and implemented to ensure all personnel are trained to perform their assigned duties.
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. The procedure appears adequate. We will verify the implementation of this procedure during our next inspection of your firm.
 
8.    Failure to establish and maintain document control procedures, as required by 21 CFR 820.40. Specifically, your firm failed to establish document control procedures to ensure the most current version of the documents are being used.
 
We reviewed your response to the Form FDA 483 received on May 28, 2013. The procedure appears adequate. We will verify the implementation of this procedure during our next inspection of your firm.
 
You 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all warning letters about devices so they may take this information into account when considering the award of contracts. 
 
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective actions you have taken.  If your planned correction will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be comprehensive and address all violations included in this Warning Letter.
 
Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility.  It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Form FDA 483, issued at the close out of the inspection, may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems.  You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your product into compliance.
 
Your response should be sent to: Ms. Kimberly Dutzek, Compliance Officer, at the address above. If you have any questions about the content of this letter please contact Ms. Dutzek via (615) 366-7826.
 
Sincerely,
/S/ 
Patricia Schafer
District Director
New Orleans District