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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Himalayan Int'l Inst. of Yoga Science and Phil. of the USA 5/24/12

  

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT

900 U.S. Customhouse.
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597·4390 

 

WARNING LETTER
12-PHI-17
 
May 24, 2012
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED
 
Mr. Rolf Sovik, President
Himalayan Institute of Buffalo
841 Delaware Avenue
Buffalo, New York 14209
 
Dear Mr. Sovik:
 
The U.S. Food and Drug Administration (FDA) conducted an inspection of your liquid dietary supplement manufacturing facility, located at 952 Bethany Turnpike, Honesdale, PA, from January 4, 2012 through January 18, 2012. The inspection found that your facility has serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111).  These violations cause your dietary supplement products identified below to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (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 CGMP requirements for dietary supplements. 
 
In addition, we have reviewed the labeling for your products and your website at www.himalayaninstitute.org. Based on our review, we have concluded that your products identified below are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You may find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
 
Dietary Supplement CGMP Violations
 
1)    You have not prepared and followed a written master manufacturing record (MMR) for each batch size of dietary supplement that you manufacture, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically,
 
  • You use blank “Formulations Logs” that contain pre-determined multiplication factors for each ingredient used in a particular product as your MMR. Before a new batch of product is manufactured, employees use this multiplication factor to determine the amounts of each ingredient that must be used based on the total batch volume that is needed. These amounts are then handwritten on the “Formulation Log.” Our review of each MMR for your products Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure revealed that the same MMR was used for multiple batch sizes. 
  • You did not follow the MMRs for the following batches of product:
 
i)    Elixir 29 Lot # (b)(4) and (b)(4)-You substituted (b)(4) for blue vervain leaf. You used many spagyric ingredients in place of herbal extracts. A 2 oz. bottle of product contains 59 ml instead of the prescribed 60 ml.
 
ii)    Sweet Dreams Lot # (b)(4)-You substituted (b)(4) and (b)(4) for skullcap herb.  You used many spagyric ingredients in place of herbal extracts. A 2 oz. bottle of product contains 59 ml instead of the prescribed 60 ml.
 
iii)    Safe Travel Lot # (b)(4)-You substituted (b)(4) for goldenseal root. You used many spagyric ingredients in place of herbal extracts. A 2 oz. bottle of product contains 59 ml instead of the prescribed 60 ml.
 
iv)    Safe Travel Lot # (b)(4)- You added extra licorice and calamus to make up for a shortage in wood betony herb. You used many spagyric ingredients in place of herbal extracts. 
 
2)    You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i). Specifically, you verbally confirmed to our investigator that you did not test or verify the identities of any dietary ingredients used in the following batches of product:
 
  • Elixir 29 - Lot #: (b)(4)
  • Immuno-Stim – Lot #: (b)(4)
  • Sweet Dreams – Lot #: (b)(4)
  • Safe Travel – Lot #: (b)(4)
  • Sages Treasure – Lot #: (b)(4) 
 
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.
 
3)    Your firm failed to qualify a supplier of a component by establishing the reliability of the supplier’s certificate of analysis (COA) through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Your firm verbally confirmed that you did not establish the reliability of your suppliers’ certificates of analysis.
 
While you must conduct, at minimum, one test or examination to verify the identity of any component that is a dietary ingredient, you may, if desired, rely on a COA for other specifications for those ingredients, and to confirm the identity of other components that are not dietary ingredients. However, you may only rely on a COA if you have met the requirements of 21 CFR 111.75(a)(2)(ii), which include qualifying the supplier.
 
4)    You failed to establish specifications for any of your dietary supplement products, such as Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure, as required by 21 CFR 111.70. Specifically:
 
  • You failed to establish specifications 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 MMR, as required by 21 CFR 111.70(a).
  • You failed to establish component specifications, as required by 21 CFR 111.70(b). 
  • You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications) as required by 21 CFR 111.70(d).
  • You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the finished batch, as required by 21 CFR 111.70(e). 
 
We also note that once you have established the above specifications, you must determine whether the specifications have been met, as required by 21 CFR 111.73.
 
5)    You failed to quarantine components before you used them in the manufacture of a dietary supplement, as required by 21 CFR 111.155(c). For example, the dietary supplement components used to manufacture the finished batches noted in item no. 2 above, were used without being quarantined. Your firm verbally confirmed to our investigator, that you do not quarantine components before they are used in the manufacturing of a dietary supplement. Prior to using components in the manufacture of a dietary supplement, you must quarantine the components until all of the requirements of 21 CFR 111.155(c)(1), (c)(2), and (c)(3) have been met.
 
6)    You failed to include required information in your MMRs for your Elixir 29, Immuno-Stim, Sweet Dreams, Safe Travel, and Sages Treasure products, as required by 21 CFR 111.210. Specifically:
 
  • Your MMR must include the identity and weight or measure of each dietary ingredient that will be declared on the Supplement Facts label and the identity of each ingredient that will be declared on the ingredients list of the dietary supplement [21 CFR 111.210(d)]. However, your MMRs do not contain water and the weight or measure of grain alcohol although they are declared on the labels for these products.
  • Your MMR must include a statement of theoretical yield of a manufactured dietary supplement expected at each point, step, or stage of the manufacturing process where control is needed to ensure the quality of the dietary supplement, and the expected yield when you finish manufacturing the dietary supplement, including the maximum and minimum percentages of theoretical yield beyond which a deviation investigation of a batch is necessary and material review is conducted and disposition decision is made [21 CFR 111.210(f)]. However, your MMRs for these products do not include this information.
  • Your MMR must include 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)]. However, your MMRs for these products do not contain this.
  • Your MMR must include written instructions, including the following: specifications for each 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 MMR; procedures for sampling and a cross-reference to procedures for tests or examinations; specific actions necessary to perform and verify points, steps, or stages 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 MMR; and, corrective action plans for use when a specification is not met [21 CFR 111.210(h)(1)-(3),(5)]. However, your MMRs for these products do not include this information. 
 
7)    You failed to include required information in your batch production records (BPRs) for your Elixir 29 (Lot #: (b)(4)), Immuno-Stim (Lot #: (b)(4)), Sweet Dreams (Lot #: (b)(4)), Safe Travel (Lot #: (b)(4)), and Sages Treasure (Lot #: (b)(4)) products, as required by 21 CFR 111.260. Specifically:
 
  • Your BPR must include the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].  However, your BPRs for these products do not include this information.
  • Your BPR must include the date and time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records, such as individual equipment logs, where this information is retained [21 CFR 111.260(c)]. However, your BPRs for these products do not include this information.
  • Your BPR must include the identity and weight or measure of each component used [21 CFR 111.260(e)]. However, the BPRs for these products do not include water, which is declared on your product labels.
  • Your BPR must include a statement of the actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)]. However, your BPRs for these products lack this information.
  • Your BPR must include documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)]. However, your BPRs for these products lack this information. As is discussed above in item no. 4, you have not established any specifications for these dietary supplement products.
  • Your BPR must include documentation, at the time of performance, of the manufacture of the batch, including the initials of the person responsible for weighing or measuring each component used in the batch, the initials of the person responsible for verifying the weight or measure of each component used in the batch, the initials of the person responsible for adding the component to the batch, and the initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)]. However, your BPRs for these products do not include any of this information.
  • Your BPR must include documentation, at the time of performance, of packaging and labeling operations including the unique identifier that you assigned to packaging and labels used, the quantity of the packaging and labels used, and, when label reconciliation is required, reconciliation of any discrepancies between issuance and use of labels; an actual or representative label, or a cross-reference to the physical location of the actual or representative label specified in the MMR; and the results of any tests or examinations conducted on packaged and labeled dietary supplements (including repackaged or relabeled dietary supplements), or a cross-reference to the physical location of such results [21 CFR 111.260(k)]. However, your BPRs for these products do not include this information.
  • Your BPR must include documentation at the time of performance that quality control personnel reviewed the BPR; approved or rejected any reprocessing or repackaging; approved and released, or rejected, the batch for distribution, including any reprocessed batch; and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)]. However, your BPRs for these products do not include this information. Your BPRs for these products do not include any documentation of review by quality control personnel.
  • Your BPR must include documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)]. However, several of your BPRs, for example, Elixir 29 Lot #(b)(4), Sweet Dreams Lot #(b)(4), and Safe Travel Lot #(b)(4), show deviations from the MMR in that ingredients other than the ones specified are used, but there is no documentation that you conducted a material review or made a disposition decision. As required by 21 CFR 111.113(a)(2), quality control personnel must conduct a material review and make a disposition decision if a batch deviates from the MMR, including when any step established in the MMR is not completed and including any deviation from specifications.
 
8)    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, as required by 21 CFR 111.103. Specifically, your firm verbally confirmed to our investigator, that no written procedures exist at your facility for the responsibilities of the quality control operations. 
 
9)    You firm failed to make and keep records of written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR 111.325(b)(1). Specifically, your firm verbally confirmed to our investigator that you did not have written procedures for laboratory operations and were not aware that these procedures had to be written.
 
10)    You failed to establish written procedures to fulfill the requirements of 21 CFR 111.560 relating to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, your firm verbally confirmed to our investigator that there is no formal system in place to address product complaints.
 
11)    You failed to establish and follow written procedures to fulfill the requirements of 21 CFR Part 111, Subpart N for handling returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures to ensure the proper disposition of returned dietary supplements. Additionally, your firm verbally confirmed to our investigator that products were returned to your facility and that there were no records available which document the final disposition of these returned dietary supplements as required by 21 CFR 111.535(b)(2).     
 
12)    You failed to routinely calibrate, inspect, or check the automated, mechanical, or electronic equipment that you use to manufacture, package, label, or hold a dietary supplement, to ensure proper performance, as required by 21 CFR 111.30(c). Specifically, your firm verbally confirmed to our investigator, that the equipment noted below was used to manufacture dietary supplements and was not calibrated:
 
  • The scale, manufactured by (b)(4), which is used to weigh all herbal ingredients; and
  • The specific gravity meter which is used to measure fine % alcohol concentration in the finished products.
 
13)    You failed to make and keep records of your written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.35(b)(1)(ii) and (iii). You also failed to make and keep written records of calibrations, inspections, and checks of automated, mechanical, and electronic equipment, as required by 21 CFR 111.35(b)(4). Specifically:
 
  • You verbally informed our investigator that the UV Water System, manufactured by (b)(4) was inspected by your firm (b)(4); however, you stated that there are no written procedures for this inspection, nor do you maintain any records of these inspections.
  • You verbally informed our investigator that there are no written procedures in place that outline the cleaning process for the lab/processing area and equipment. 
 
Unapproved New Drugs:
 
Your product labels and website, www.himalayaninstitute.org, promote your products for conditions that cause the products identified below to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims on your product labels and website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of the claims found on your product labels and website include:
 
Inflam-away label
 
  • The name of your product implies that your product reduces inflammation
 
Himalayan Triphala Oil webpage:
 
  • “Ayuredic practitioners have traditionally used ‘medicated’ or treated oils topically to assist with conditions such as . . . eczema, psoriasis, and dermatitis . . . .”
  • “Sesame oil [ingredient in the product] . . . is considered to be effective in treating the pain and swelling of rheumatoid arthritis . . . .”
  • “Due to this lecithin content it is believed to . . . alleviate . . . depression . . . .”
  • “It may also be used as a mouthwash (called oil pulling) for problem gums and inflammation.”
 
Namastea Black webpage
 
  • “[B]lack tea may protect against certain types of heart disease while having a favorable influence on blood lipid levels.”
  • “[T]hese compound [antioxidants] are helpful in supporting the body’s immune function in preventing cancer . . . .”
 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)].   A new drug may not be legally marketed in the United States without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. 
 
Further, your Himalayan Triphala Oil and Namastea Black products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these products safely for their intended uses. Thus, the labeling fails to bear adequate directions for the products’ intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
Misbranded Food
 
Under section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)], a claim made in the label or labeling of a food that characterizes the level of any nutrient which is of the type required to be in the label or labeling of the food (a “nutrient content claim”) must be made in accordance with regulations promulgated by the Secretary (or, by delegation, FDA). The use of a term, not defined by regulation, in food labeling to characterize the level of a nutrient misbrands a product under section 403(r)(2)(A)(i) of the Act [21 U.S.C. § 343(r)(2)(A)(i)].
 
Nutrient content claims that characterize the level of antioxidant nutrients present in a food must also comply with the specific requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, an RDI must have been established for each of the nutrients that are the subject of the claim (21 CFR 101.54(g)(1)), and these nutrients must have recognized antioxidant activity (21 CFR 101.54(g)(2)). The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) (21 CFR 101.54(g)(3)). For example, to bear the claim "high in antioxidant vitamin C," the product must contain 20 percent or more of the RDI for vitamin C. Such a claim must also include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" when used as part of a nutrient content claim such as “high in antioxidants” may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity (21 CFR 101.54(g)(4)). The use of a nutrient content claim that uses the term "antioxidant" but does not comply with the requirements of 21 CFR 101.54(g) misbrands a product under section 403(r)(1)(A) of the Act.
 
Your webpage entitled "Namastea Black (225g Bag)" at www.himalayaninstitute.org includes the claims, "Black tea is recognized for its rich concentration in antioxidant polyphenols such as EGC, EGCG, and other flavonols . . . .”  and “Loaded with protective antioxidant polyphenols.” The terms "rich concentration” and “[l]oaded with” characterize the level of antioxidant nutrients in the product and, therefore, these claims are nutrient content claims (see section 403(r)(1)(A) of the Act and 21 CFR 101.13(b)). Even if we determined that the terms "rich concentration" or “[l]oaded with” could be considered synonyms for terms defined by regulation (e.g., "high" or "good source"), nutrient content claims that use the term "antioxidant" must meet the requirements of 21 CFR 101.54(g). These claims do not comply with 21 CFR 101.54(g)(1) because no RDI has been established for polyphenols, EGC, EGCG, or flavonols. Thus, these unauthorized nutrient content claims cause your product to be misbranded under section 403(r)(1)(A) of the Act.
 
Your Adapt-a-gem product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. 343(u)] in that it is represented as containing ginseng, but the purported ginseng ingredient is not from a plant classified within the genus Panax. The ingredient statement for your product lists Siberian Ginseng (Eleutherococcus senticosus). Section 10806(b)(1) of the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171) provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Therefore, Eleutherococcus senticosus may not be declared under a name that includes the term "ginseng."
 
Your Adapt-a-gem and Cholesta-low products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the label fails to bear nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36. In addition, should you decide to change the name of your Inflam-away product so that it no longer promotes it as an unapproved new drug, as stated on page seven (7) of this letter, it  would then become a misbranded dietary supplement within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)], in that the label fails to bear nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36.
 
Your Cholesta-low product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2] in that the ingredients statement does not list the ingredient He Shou Wu root by the common or usual name. In accordance with 21 CFR 101.4(h), the common or usual name of ingredients of dietary supplements that are botanicals shall be consistent with the names standardized in Herbs of Commerce, 1992 edition. The common name for He Shou Wu in Herbs of Commerce is Fo-Ti.
 
The above violations are not intended to be an all-inclusive list of violations at your facility and with your products, labels, and labeling. It is your responsibility to ensure that your products are in compliance with all applicable statutes and regulations, including the Act, the CGMP regulations for dietary supplements, and FDA’s food labeling regulations. 
 
You should take prompt action to correct the violations described in this letter. Failure to take appropriate corrective action may result in FDA taking regulatory action without further notice, such as injunction or seizure.
 
Further, 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.
 
In addition to the above violations, we also have the following concerns:
 
  • You were unable to provide any documentation to indicate that you have performed training of your personnel. Our investigator was informed that most of the training is done on-the-job; however the firm does not document this training. Under 21 CFR 111.14(b)(2), you must make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained.
  • You have not formally identified personnel to be responsible for your quality control operations. Specifically, you verbally confirmed to our investigator that while there is an employee who has been informally filling the role of quality control, no one has been formally designated for this position. Under 21 CFR 111.12(b), you must identify who is responsible for your quality control operations. Each person who is identified to perform quality control operations must be qualified to do so and have distinct and separate responsibilities related to performing such operations from those responsibilities that the person otherwise has when not performing such operations.
  • As noted above, your batch production records indicate several instances where ingredients listed in the master manufacturing records were replaced with other ingredients. Under section 403(s)(2)(A)(i) of the Act [21 U.S.C. §343(s)(2)(A)(i)], a dietary supplement is misbranded if its label or labeling fails to list the name of each ingredient of the supplement that is described in section 321(ff) of the Act [21 U.S.C. § 201(ff)].  
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter of the specific steps that you have taken to correct the violations listed in this letter and to prevent their recurrence. Your response should include documentation of the corrective actions that you have taken or that you plan to take to correct these violations, including the specifics of what methods and controls you have implemented or plan to implement to prevent the recurrence of the violations. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and include a timetable for the implementation of the remaining corrections.
 
Your written response should be sent to Lynn S. Bonner, Compliance Officer at the address noted above. If you have any questions concerning this letter, please contact Compliance Officer Bonner at 215-717-3074 or by email at Lynn.Bonner@fda.hhs.gov.
 
Sincerely,
/S/
Kirk Sooter
District Director
Philadelphia District
 
cc:       
Gregory P. Copitolo, Director, Business Operations & Development
Himalayan International Institute of Yoga Science and Philosophy of the USA
952 Bethany Turnpike
Honesdale, PA 18431-4194
Attention:
 
Pennsylvania State Department of Agriculture
Bureau of Food Safety and Laboratory Services
2301 North Cameron Street
Harrisburg, PA 17110-9408
Attention: Dr. Lydia Johnson, Director