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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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DNE Nutraceuticals Inc. 8/2/13

 

  

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

Public Health Service
Food and Drug Administration
 New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969 

 

August 2, 2013
 
WARNING LETTER
 
 
VIA - UNITED PARCEL SERVICE
 
Mr. Sam F. Zeldes,
President
DNE Nutraceuticals, Inc.
700 Central Avenue
Farmingdale, New Jersey 07727
                                                                                                13-NWJ-12
 
Dear Mr. Zeldes:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, located at 700 Central Avenue, Farmingdale, New Jersey from February 19, 2013 through March 11, 2013. Serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations were documented during this inspection. These violations cause your dietary supplement products to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet 21 CFR part 111, Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These CGMP violations were listed on the Inspectional Observations (FDA-483) form issued to you at the close of the inspection on March 11, 2013. 
 
Furthermore, your products (b)(4) are misbranded within the meaning of section 403 of the Act [21 U.S.C. 343], as detailed below.
  
You may find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov.
 
Our investigator observed the following significant dietary supplement CGMP violations:
  
1.    Your firm failed to establish specifications as required by 21 CFR § 111.70, as follows:
 
a.    A specification for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record [21 CFR § 111.70(a)];
b.    Specifications for the in-process production to include:
 
i.    Specifications for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement [21 CFR § 111.70(c)(1)], and
ii.    Adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement [21 CFR § 111.70(c)(2)], and
iii.    Quality control personnel must review and approve the documentation that you provide [21 CFR § 111.70(c)(3)];
 
c.    Finished product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR § 111.70(e)].
 
You must make and keep records for specifications established, as required byper 21 CFR § 111.95, including documentation for why meeting in-process specifications helps ensure that the dietary supplement meets the specifications for identity, purity, strength, and composition, per 21 CFR § 111.95(b)(3). Once you establish specifications, you must verify that specifications are met, in accordance with 21 CFR § 111.73 and 21 CFR § 111.75(c).
 
Specifically, you confirmed to our investigator that your firm does not have specifications for any in-process materials or any finished dietary supplement products.
 
We reviewed your written response letter, dated March 22, 2013, including your proposed draft master manufacturing record for your “(b)(4)” product and found it to be inadequate, as it does not include documentation which establishes specifications.  For example, in (b)(4) You have not provided information on how your firm established the specification for the mixing time, and how this mixing time will help ensure that the specifications are met for the identity, purity, strength, and composition of the dietary supplements per 21 CFR § 111.70(c)(2). As an additional example, (b)(4) but you have not determined the weight of the ingredient after the sieving to verify the weight of the ingredient for use in the manufacture of the dietary supplement.
 
2.    Your firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient prior to its use, as required by 21 CFR § 111.75(a)(1)(i). Specifically, you did not perform any tests or examinations to verify the identity of the dietary ingredients used to manufacture any of your finished dietary supplements, including those identified in the table below. Before using a component that is a dietary ingredient, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition FDA under 21 CFR § 111.75 (a)(1)(ii) and FDA exempts you from such testing. Your firm has not petitioned FDA for such an exemption.
 

Product
Lot #s
Dietary Ingredients
(b)(4)
90 count bottle, lot # 1964
180 count bottle, lot # 1572.
(b)(4)
(b)(4)
60 count, lot # 132509.           
(b)(4)
(b)(4)
60 count bottle, lot # 2224
(b)(4)
(b)(4)
150 count bottle, lot # 2308.
(b)(4)

 
We reviewed your written response letter, dated March 22, 2013, including your draft standard operating procedure, and found it to be inadequate, as it does not identify appropriate testing for the products’ dietary ingredients.
 
3.    You failed to confirm the identity of other components (not including dietary ingredients) and determine whether other applicable component specifications established in accordance with § 111.70(b) are met, as required by 21 CFR § 111.75(a)(2). This requirement may be met by either conducting appropriate tests or examinations, per 21 CFR § 111.75(a)(2)(i); or by relying on a certificate of analysis (COA) from the supplier of the component that you receive, provided that, among other requirements, you first qualify your component suppliers by establishing the reliability of the supplier’s COA through confirmation of the results of the supplier’s’ tests or examinations, as per 21 CFR § 111.75(a)(2)(ii)(A).
 
Specifically, your firm was unable to provide documentation for qualifying your supplier(s) for the following products:
 

Product
Lot #s
Non-Dietary Ingredients
(b)(4)
60 count, lot # 132509.           
(b)(4)

 
4.      Your firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement you manufacture, and for each batch size, to ensure uniformity in the finished batch, as required in 21 CFR §§ 111.205 and 111.210. Specifically, written master manufacturing records have not been established for any of the dietary supplements manufactured by your firm, including:
 
a.    (b)(4) chewable tablets, fruit punch, 60 count bottle
b.    (b)(4) chewable tablets, fruit punch, 90 count and 180 count bottles
c.    (b)(4) chewable tablets, orange, 90 count bottle
d.    (b)(4) capsules, 60 count bottle
e.    (b)(4) formula tablets, 150 count bottle
f.    (b)(4) capsules, 90 count bottle
g.    (b)(4) 120 count bottle.
 
We reviewed your written response letter, dated March 22, 2013, including a draft master manufacturing record, and found it to be inadequate. The proposed draft master manufacturing record for your (b)(4) product does not include the following required information:
 
a.    A description of packaging and a representative label, or a cross-reference to the physical location of the actual or representative label [21 CFR § 111.210(g)]
b.    Procedures for sampling and a cross-reference to the procedures for tests or examinations [21 CFR § 111.210(h)(2)]
c.    Corrective action plans for use when a specification is not met [21 CFR § 111.210(h)(5)].
 
5.    Your firm’s batch production records did not include complete information relating to the production and control of each batch of your dietary supplement products as required by 21 CFR § 111.255(b), and did not include all information required to be in a batch production record per 21 CFR § 111.260. Specifically:
 
The batch production records for your (b)(4) fruit punch, 60 count bottle” (lot # 132509) failed to include:
 
a.    The batch number [21 CFR § 111.260(a)] – This was missing from the labor log sheet that indicates the initial blending date (11/9/12), and from the weight check sheets dated 1/22/13.
b.    Documentation at the time of performance of any reprocessing [21 CFR § 111.260(n)] – Our inspector observed that the lot was re-blended with four additional ingredients: bitter mask natural, natural color cherry microfine, fruit punch flavor, and stearic acid powder.
c.    The tablet press used [21 CFR § 111.260(b)] – This was missing from the weight check sheets dated 1/22/13.
d.    The weight of each component used specification [21 CFR § 111.260(ef)] – This was missing from the weight check sheets dated 1/22/13.
e.    The initials of the employee performing each step [21 CFR § 111.260(j)(2)] – This was missing from the weight check sheets dated 1/22/13.
f.    Records of friability and disintegration testing [21 CFR § 111.260(h)].
 
The batch production records for your (b)(4), 90 count bottle” (lot # 1964) and 180 count bottle (lot # 1572) failed to include:
 
a.    Documentation at the time of performance of any reprocessing [21 CFR § 111.260(n)]The blending record did not document changes in the blending procedure. (that the active ingredients were divided and re-blended with inactive ingredients). There was no record for the reblending.
b.    Documentation at the time of performance of any required material review and disposition decision [21 CFR § 111.260(m)] –  The blend sheets did not document a material review for changes from vitamin D3 1000IU on the original blend sheet to vitamin D3 200IU on the re-blend sheet.
c.    The tablet press used [21 CFR § 111.260(b)] – This was missing from the weight check sheets dated 8/27/12 and 8/28/12.
d.    The initials of the employee performing each step [21 CFR § 111.260(j)(2)] – This was missing from the weight check sheets dated 8/27/12 and 8/28/12.
 
The batch production records for your “(b)(4), orange, 90 count bottle” (lot # 1729) failed to include:
 
a.    The identity of each component used in the original blending, and the weight or measure of each component used in the original blending and in the re-blending [21 CFR § 111.260(e)].
b.    The blending date for the original formulation [21 CFR § 111.260(j)] – The  labor log sheet did not include an original blending date.
c.    Documentation at the time of performance of any reprocessing [21 CFR § 111.260(n)] – There was no record for re-blending the unused in-process ingredients with new ingredients.
 
We have reviewed your written response letter, dated March 22, 2013, and found it to be inadequate.  Your response appears to address the master manufacturing records and not the batch records.  
 
6.    You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing in accordance with 21 CFR § 111.103. In addition, your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplements and that the dietary supplements are packaged and labeled as specified in the master manufacturing record in accordance with 21 CFR § 111.105. Specifically, you have not established any processes, specifications, written procedures, controls, tests, and examinations for review and approval by your quality control personnel.
 
We reviewed your response letter, dated March 22, 2013, and found it to be inadequate, as it does not provide documentation of procedures for adequate quality control and that the procedures are being followed.
 
7.    Your firm failed to hold dietary supplement components and in-process materials under conditions that would prevent their mixup, contamination, or deterioration, as required by 21 CFR § 111.455(c). Specifically, our investigator observed dietary supplement ingredients and in-process materials being stored outside designated areas, such as in hallways.  Containers were not consistently labeled.
 
We have reviewed your response letter, dated March 22, 2013, including the new SOP, and found it to be inadequate, since it does not include documentation which indicates that the proposed changes have been implemented.
 
8.    Your firm failed to collect representative samples of a subset of finished batches of each dietary supplement that you manufacture, which you identify through a sound statistical sampling plan (or otherwise every finished batch),  before releasing for distribution to verify that the finished batch of dietary supplement meets established product specifications, as required by 21 CFR § 111.80(c). Specifically, you failed to collect a representative sample for each product before distribution to verify that the finished batches met product specifications established under 21 CFR § 111.70(e), and as applicable, 21 CFR § 111.70(a). Your firm collects 1 unit per batch, regardless of batch size, as the representative sample of each finished batch. There was no documentation that 1 unit per batch was determined through a sound statistical sampling plan as being representative of the finished batch.
 
We have reviewed your response letter, dated March 22, 2013, including the new SOP, and found it to be inadequate, since it does not include documentation which indicates that the proposed changes have been implemented, nor does it establish sampling on the basis a sound statistical sampling plan, per 21 CFR § 111.80(c).
 
9.    Your equipment and utensils used in the manufacturing of dietary supplement products are not maintained to prevent contamination as required by 21 CFR § 111.27(a)(3)(v). The following incidents were observed by our investigator during our inspection:
 
a.    On 2/25/13, the 30 cubic ft. (b)(4) was cleaned; however, the bottom release valve retained an accumulation of black residue. The valve area was then dried with a towel, which became. The valve was stained from the black residue. The white gasket at the bottom release valve was worn and discolored.   
b.      On 2/20/13, green, blue, and yellow buckets that were stored in the weighing and sieving room were covered with a powder residue. Your employees lined the buckets with plastic bags and filled the buckets with dietary supplement ingredients. The buckets were transported to blending rooms, where the dietary supplement ingredients were scooped from the buckets into the blender.  The buckets weare returned to the weighing and sieving room without cleaning or sanitizing and were used in manufacturing multiple dietary supplements.
c.    The (b)(4) (semi-automatic encapsulation machine) was not adequately cleaned before manufacturing Resveratrol capsules, lot # 2721. The chamber where the capsules were put together had a white powder residue. Resveratrol is a light brown powder.  The capsule hopper lid on the (b)(4) machine was replaced with a piece of cardboard. Your employee responsible for cleaning the machine did not know the procedure to clean the chamber. 
d.    On 2/19/13, in Room 11, an employee used a frayed and stained medium sized wooden paintbrush to push bitter melon powder down into the (b)(4) hopper.
e.    On 2/20/13, in Room 11, an employee stored a dietary supplement residue covered stainless steel scoop on a cardboard box of capsules, an unclean and unsanitary surface. Without being washed, the scoop was later used to scoop empty capsules into the (b)(4) machine. The remaining empty capsules were returned to inventory to be used for other dietary supplements.
f.    On 2/20/13, two fiber drums stored in the (b)(4) cubic ft. (b)(4) Room had an accumulation of particulates at the bottom. Your employees used these drums to collect blended dietary supplement ingredients. These fiber drums were observed being re-used for storing dietary supplements and in-process dietary supplement ingredients and were left throughout the facility outside designated holding areas.
 
We have reviewed your response letter, dated March 22, 2013, including your new SOP, and found it to be inadequate, since it does not include documentation which indicates that the proposed changes have been implemented.
 
Based on our review of the labeling for your products (b)(4) we have determined that they are misbranded under section 403 of the Act, as follows:
 
1.    The “(b)(4)” product is misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B) of the Act [21 U.S.C. §§ 343(i)(1) and 343(s)(2)(B)] in that the label fails to identify the product using the term “dietary supplement,” or other appropriately descriptive term, in accordance with 21 CFR § 101.3(g).
 
2.    The (b)(4)” and “(b)(4)” products are misbranded within the meaning of section 403(q)(5)(F)  [21 U.S.C. § 343(q)(5)(F)] of the Act [21 U.S.C. § 343(q)(5)(F)] in that the labels fail to comply with 21 CFR § 101.36.  Specifically:
 
a.    The “(b)(4)” label fails to bear nutrition information in the form of a Supplement Facts panel in accordance with 21 CFR § 101.36.  Nutrition information for a dietary supplement shall be presented with the title, “Supplement Facts,” and shall be enclosed in a box by using hairlines in accordance with 21 CFR § 101.36(e)(1) and (2).
 
b.    The (b)(4) label declares “(b)(4) (calcium carbonate, bromelain, papain, lipase, amylase, protease, and silica)” but does not declare the quantities per serving of calcium carbonate and the enzymes (e.g., bromelain) in the (b)(4) digestive enzyme complex.  If a dietary supplement product contains (b)(2)-dietary ingredients  or other (i.e., (b)(3))-dietary ingredients, then the dietary ingredients must be declared in the nutrition information in accordance with 21 CFR § 101.36(b)(2) and (b)(3).
 
3.    The “(b)(4)” product is misbranded within the meaning of section 403(q)(1)(A) [21 U.S.C. 343(q)(1)(A)] of the Act [21 U.S.C. 343(q)(1)(A)] because the label fails to declare the correct serving size, as required by 21 CFR § 101.36(b)(1).  Specifically, the serving size for a dietary supplement must be determined in accordance with 21 CFR § 101.9(b) and 21 CFR § 101.12(b), Table 2.  Under 21 CFR § 101.9(b)(2), the serving size must be determined from the “Reference Amounts Customarily Consumed Per Eating Occasion” (RACCs) that appear in § 101.12(b).  The RACC for dietary supplements is the maximum amount recommended, as appropriate, on the label for consumption per eating occasion.  The labeling for (b)(4) states, “directions for use suggest 1-2 capsulesTake 1 to 2 capsules after each meal, 3 times a day.” Therefore, the serving size must be based on a RACC of 2 capsules. However, the labeling incorrectly declares the serving size as 1 capsule. 
 
4.    The “(b)(4)” product is misbranded within the meaning of section 403(q)(1)(B) [21 U.S.C. 343(q)(1)(B)] of the Act [21 U.S.C. 343(q)(1)(B)] in that the declared number of servings per container is incorrect. The number of servings per container (120) is not correct based upon the number of capsules listed as the net quantity of contents (60 capsules) and the serving size (1 capsule).
 
5.    The “(b)(4)” and “(b)(4)” products are misbranded within the meaning of section 403(s)(2)(C) [21 U.S.C. 343(s)(2)(C)]  of the Act [21 U.S.C. 343(s)(2)(C)] in that the labels fail to identify the part of the plant (e.g., root, leaves) from which each botanical ingredient in the product is derived, as required by21 CFR § 101.4(h)(1).
 
6.    The “(b)(4)” products are misbranded within the meaning of section 403(y) [21 U.S.C. § 343(y)] of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person, as described in section 761(b) of the Act [21 U.S.C. § 379aa-1(b)], may receive reports of serious adverse events associated with the products.
 
7.    The “(b)(4)” product is misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the label fails to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR § 101.5. 
 
The above violations are not intended to be an all-inclusive list of deficiencies at your facility and in your labeling. It is your responsibility to ensure that all of your firm’s products are in compliance with federal laws and regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct the violations may result in legal action without further notice, including seizure or injunction.
 
In addition to the violations discussed above, we offer the following CGMP comments, relevant to your products:
 
  • During the inspection, you informed our investigator that your employees who engage in quality control operations are not familiar with dietary supplement CcGMP requirements and do not understand how to establish and follow quality control procedures. Under 21 CFR § 111.12(c), personnel engaged in quality control operations must have the education, training, or experience to perform their assigned functions.
 
We have reviewed your response letter, dated March 22, 2013. You state in your letter that you have started the hiring process to find a qualified QC manager and hope to have one in place within (b)(4). However, you do not specify in your letter what qualifications you require of the QC manager or of other quality control personnel. 
 
  • Our investigator observed your personnel using gloves that were not clean. Specifically, an employee was observed failing to wear intact, clean, and sanitary gloves when in direct contact with dietary supplement blend. Under 21 CFR § 111.10(b) employees must use hygienic practices to the extent necessary to protect against contamination when working in an operation during which adulteration of the component, dietary supplement, or contact surface could occur. Under 21 CFR § 111.10(b)(5), gloves used in handling components or dietary supplements must be maintained in an intact, clean and sanitary condition.
 
We have reviewed your response letter, dated March 22, 2013. You state in your letter, “The SOP is implemented and enforced.” However, you did not enclose a copy of the SOP or specify how your SOP is being implemented and enforced.
 
  • Our investigator noted that you did not maintain your physical plant in a clean and sanitary condition. For example, the weighing and sieving room floor was covered with an off-white powder residue, causing employees walking in and out of this room to track the powder residue to other.
 
We have reviewed your response letter, dated March 22, 2013. You state in your draft SOP what the responsibilities and procedures would be for cleaning and maintaining a clean facility. However, you did not provide documentary evidence that the SOP is being implemented and enforced.
 
  • Your physical plant was not designed and constructed in a manner that prevents contamination. Specifically, your fixtures and ducts were not designed and constructed so that they do not contaminate components, dietary supplements, or contact surfaces by dripping, leakage, or condensate.
 
We have reviewed your response letter, dated March 22, 2013. You state in your letter, “We are investing in additional equipment to enhance our ventilation as well as replacing equipment noted in the observation as non-compliant. We will have this done within 6-8 months.” However, you do not specify what equipment you are purchasing and how the new equipment will prevent contamination.
 
  • Your firm did not have appropriate documentation pertaining to equipment and utensils. For example,
 
a.    There were no written calibration or maintenance procedures for the following manufacturing equipment to ensure that the equipment is meeting the operating limits to produce dietary supplements that meet specifications: (b)(4) Under 21 CFR § 111.35(b)(1)(ii), you are to maintain written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.
b.    Your firm did not have maintenance, cleaning, and sanitizing records for certain equipment used to manufacture dietary supplements. For example:
 
  • On 2/25/13, our investigator observed two of your employees blending dietary supplement ingredients for (b)(4). Your employees did not record the cleaning and sanitizing procedures that were performed. In fact, your firm did not maintain any cleaning and sanitizing records for this blender.
  • Your firm did not keep maintenance, cleaning, and sanitizing records for the following equipment and utensils used to manufacture dietary supplements: (b)(4) Under 21 CFR § 111.35(b)(2), you are to keep maintenance, cleaning, and sanitizing records for equipment.
 
c.       There were no calibration records for the analytical balances used to perform weight checks on the following production dates:
 
  • On 2/19/13, the analytical balance in Room 11 used to measure the weight of (b)(4) capsules, lot # 2770
  • On 2/2/19/13, the analytical balance in Room 12 used to measure the weight of Seaweed powder capsules, lot # 2917
  • On 2/20/13, the analytical balance in Room 2 used to measure the weight of (b)(4) chewable tablets, orange, lot # 1729
  • On 2/20/13, the analytical balance in Room 11 used to measure the weight of (b)(4) capsules, lot # 2721
  • On 2/20/13, the analytical balance in Room 13 used to measure the weight of (b)(4) capsules, lot # 2864
  • On 2/25/13, the analytical balance in Room 12 used to measure the weight of (b)(4) capsules, lot # 2783.
 
Under 21 CFR § 111.35(b)(3), you are to maintain documentation of calibrations for instruments and controls that you use in manufacturingor testing a dietary supplement or component.
 
As a final comment, we have reviewed your response letter, dated March 22, 2013. You state that two draft SOPs are “currently being implemented” but have provided no documentary evidence.  For example, your draft SOP for “Facility Cleaning” (document number 3-11) states, “Outside of individual production room doors and windows will be kept clean and dust free. Doors and windows will be wiped clean using a disposable rag and proper cleaning agent.” However, you have provided no evidence, such as photos, to indicate the changes have been implemented.
 
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations, including an explanation of each step taken to prevent the recurrence of violations, and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction.
 
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.
 
Your response should be sent to the following address: U.S. Food and Drug Administration, 10 Waterview Blvd., Parsippany, New Jersey 07054. If you should have any questions regarding any issue in this letter, please contact Andrew Ciaccia, Compliance Officer at 973-331-4904.
 
Sincerely,
/S/  
Diana Amador-Toro
District Director
New Jersey District