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WARNING LETTER

Secret Garden of Health & Healing, LLC MARCS-CMS 538408 —


Recipient:
Recipient Name
Doris B. Kunz
Secret Garden of Health & Healing, LLC

4067 S 4400 W

West Valley City, UT 84120-4005
United States

Issuing Office:
Denver District Office

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
P.O. Box 25087
Denver, CO 80225 

 

March 21, 2018
 
WARNING LETTER
 
 
Via UPS Overnight
 
 
Doris B. Kunz
Co-Owner
Secret Garden of Health & Healing
4067 S 4400 W
West Valley City, UT 84120-4005
 
 
Ref #: HAF4W(DEN)-18-05-WL
 
 
Dear Ms. Kunz:
 
From August 21 - 29, 2017, the U.S. Food and Drug Administration (FDA or we) conducted an inspection of your manufacturing facility located at 4067 S 4400 W, West Valley City, Utah.  During the inspection, we also collected labeling for your products. Based on the inspectional findings, a subsequent review of the product labels collected during the inspection, and a subsequent review of your website at www.secretgardenofhealthandhealing.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
 
Unapproved New Drugs/Misbranded Drugs
 
This is to advise you that the FDA reviewed your website at the Internet address www.secretgardenofhealthandhealing.com in February 2018 and has determined that you take orders there for the products: Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, and BP Formula. FDA also reviewed product labels for S.G. Cough Syrup, Bac-ta Bitters, Anti-Viral, Kidney/Bladder, Can D da, Staph/Strep, EnnerLite, Cayenne, B-Alergone, BP Formula, and End O Me following an inspection of your facility at 4067 S 4400 W, West Valley City, Utah between August 21, 2017 and August 29, 2017. The claims on your labels and website establish that the products are drugs under Section 201(g)(1)(B) of the Act [21 USC § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
 
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
 
Under the “Products” tab/ “Single Tinctures”/ “Quick Overview” and “Customer Review” sections
 
Osha Root
  • “Osha Root has been used by Native Americans for eons when they had a cough or sore throat.” 
Under “Products” tab/ “Tinctures”/ “Quick Overview” and “Customer Review” sections
 
Bac-ta-Bitters
  • “Great support for a healthy, infection free system. Some symptoms of bacterial infection could be fever, vomiting, diarrhea, fatigue, cramping, bloating, cloudy urine, inflammation and more.” 
A V Complete or Anti-Viral
  • “Support for a healthy immune system. Some symptoms of a viral infection can be coughing, cramping, fatigue, fever, inflammation, diarrhea, vomiting, sneezing, or Shingles.”
  • The web address: “https://secretgardenofhealthandhealing.com/collections/tincture/products/anti‐viralshingles”
K B Complete or Kidney/Bladder
  • “Do you have stones? Pain? . . . One symptom of kidney issues could be sciatic pain.” 
C D A Complete or Can D da
  • “Do you have Candida symptoms? Common symptoms of Yeast Overgrowth could be, bad breath, rash, vaginal discharge, thrush, itching of vagina, anus, or ears.” 
S/S Complete or Staph/Strep
  • “This formula . . . supports a healthy body, free of staph or strep issues. Common symptoms of strep or staph are; [sic] fever, sore throat, unexplained open sores, red or inflamed tonsillitis, swollen and tender lymph nodes on the sides of the upper neck, white spots on the tonsils.” 
B-Alergone
  • “Do you have allergies and hay fever?”
E O Support or End O Me
  • “(Q4 Endocrine 5E) Are you suffering with symptoms of endometriosis?” 
Examples of some of the claims on your product labels that provide evidence that your products are intended for use as drugs include:
 
S.G. Cough Syrup (single tincture)
  • “Historically used to sooth [sic] a sore throat and stop a cough.”
  • The name of the product
Bac-ta-Bitters (tincture)
  • “Herbs historically used for bacterial infections, reported to work well for urinary tract infections” 
Anti-Viral (tincture)
  • “Support for Shingles”
  • The name of the product
  • “Historically used for severe viral infections, such as shingles and respiratory viruses.”
Kidney/Bladder (tincture)
  • “[M]ay dissolve stones . . . .”
Can D da (tincture)
  • Historically used for thrush,…flu, earache, or congestions 
Staph/Strep (tincture)
  • “Historically used for staph or strep infections.”
  • The name of the product 
EnnerLite (capsules)
  • “Historically used for . . . depression, and anxiety.”
Cayenne (single tincture)
  • “Historically used to clean out arteries and stop bleeding.” 
B-Alergone (tincture)
  • “Historically used to relieve allergies and hay fever.”
BP Formula (tincture)
  • “Historically used to help lower blood pressure.” 
End O Me (tincture)
  • “Endometriosis Support”
  • “Historically used when symptoms of endometriosis are indicated.” 
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 USC § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in Sections 301(d) and 505(a) of the Act [21 USC §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug is misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in Section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products A V Complete or Anti-Viral, S/S Complete or Staph/Strep, E O Support or End O Me are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use these products safely for their intended purposes. Accordingly, A V Complete or Anti-Viral, S/S Complete or Staph/Strep, E O Support or End O Me, fail to bear adequate directions for their intended use and, therefore, the products are misbranded under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates Section 301(a) of the Act [21 U.S.C. § 331(a)].
           
Dietary Supplement CGMP Violations
 
Our investigators observed the following significant violations of FDA’s Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), which render your dietary supplement products adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)]. Additionally, even if your Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, and BP Formula products did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] for the reasons described below. 
 
We acknowledge receipt of your written response, dated September 13, 2017, to the observations reported to you on the FDA-483, Inspectional Observations. However, we are unable to evaluate the adequacy of your corrective actions because you did not provide documentation to assist us in verifying any corrective actions you state you are taking or intending to take, and you did not address all the observations identified on the FDA-483.
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
1.    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 and 21 CFR 111.140(b)(1). Specifically, you have no written procedures for the responsibilities of the quality control operations.
 
Further, we note that once you have established written quality control procedures, you must implement quality control operations into your manufacturing, packaging, labeling, and holding operations for producing dietary supplements to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, in accordance with 21 CFR 111.65.
 
We have reviewed your response letter dated September 13, 2017; however, we are unable to evaluate the adequacy of your intended corrective actions. In your response, you state that your intention is to (b)(4) that will (b)(4); however, you have not provided documentation to demonstrate that you have (b)(4) or that you have established and implemented quality control operations at your facility.
 
We note that even if you do (b)(4), you will still need to implement quality control operations that would apply to you and your operations as a distributor. In addition, to the extent that (b)(4) that your firm releases for distribution under your firm’s name, you have an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)].
 
2.    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 master manufacturing record, as required by 21 CFR 111.70(a).
 
Specifically, you failed to establish the following component specifications for each component that you use in the manufacture of a dietary supplement:
  • Identity specification [21 CFR 111.70(b)(1)];
  • Component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met [21 CFR 111.70(b)(2)]; and
  • Specifications that establish the limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement [21 CFR 111.70(b)(3)];
Further, you failed to establish specifications, for each dietary supplement that you manufacture, 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, as required by 21 CFR 111.70(e).
 
We note that once you have established these specifications, you must determine whether the specifications that you establish under 21 CFR 111.70 are met, as required by 21 CFR 111.73 and 21 CFR 111.75(c). Specifically, once you have established component specifications and before using a component, you must 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), unless you petition the agency under 21 CFR 111.75(a)(1)(ii) and the agency exempts you from such testing. You must also confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Further, you must verify that your finished batch of the dietary supplement meets product specifications for the identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c).
 
You must also make and keep records, including records for the specifications you establish, in accordance with 21 CFR 111.95.
 
We have reviewed your response letter dated September 13, 2017; however, we are unable to evaluate the sufficiency of your intended corrective actions. You state your intent is to (b)(4) that will (b)(4); you have not provided documentation in your response to demonstrate you have (b)(4) for this purpose or that you have established the aforementioned specifications.
 
3.    You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch as required by 21 CFR 111.205(a).
 
Specifically, during the inspection, you stated you had not established MMRs for any of the approximately (b)(4) dietary supplement products you produce.
 
We have reviewed your response letter dated September 13, 2017; however, we are unable to evaluate the adequacy of your intended corrective actions. In your response, you state your intent is to (b)(4) that (b)(4); you have not provided documentation in your response to demonstrate you have (b)(4) or that you have prepared and followed a written MMR at your facility that includes all required elements, in accordance with 21 CFR 111.210.
 
4.    Your batch production record (BPR) failed to include complete information relating to the production and control of each batch and did not include all information required in a BPR, as required by 21 CFR 111.255(b) and 111.260. Specifically, batch records reviewed for Bac-ta-Bitters, batch (b)(4); Lobelia Leaf, batches (b)(4); Slippery Elm, batches (b)(4); Reproductive Tonic, batch (b)(4); Comfrey Root, batches (b)(4); Congest Free, batch (b)(4); Comfrey Leaf, batches (b)(4); Quick Repair, batch (b)(4); Baby Burp, batch (b)(4); Plantain Leaf, batches (b)(4); Golden Seal batches (b)(4), did not include the following required information:
  • Identity of equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
  • Date and time of the maintenance, cleaning, and sanitizing of 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)];
  • A statement of actual yield and percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)];
  • Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) [21 CFR 111.260(i)];
  • Documentation, at the time of performance, of the initials of the persons performing each step, including:
o   The initials of the person responsible for weighing or measuring of each component [21 CFR 111.260(j)(2)(i)];
o   The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)];
o   The initials of the person responsible for adding the component to the batch [21 CFR 111.260(j)(2)(iii)]; and
o   The initials of the person responsible for verifying the addition of components to the batch [21 CFR 111.260(j)(2)(iv)].
  • Documentation, at the time of performance, of packaging and labeling operations, including:
o   The unique identifier assigned to packaging and labels used and quantity used [21 CFR 111.260(k)(1)]; and
o   An actual or representative label or a cross-reference to the physical location of the actual or representative label specified in the master manufacturing record [21 CFR 111.260(k)(2)].
  • Documentation, at the time of performance that quality control personnel:
o   Reviewed the batch production record [21 CFR 111.260(l)(1)];
o   Approved and released, or rejected, the batch for distribution, including reprocessed batch [21 CFR 111.260(l)(3)]; and
o   Approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(4)].
 
You failed to have in place the quality control operations required for reviewing and approving the batch production records as required 21 CFR 111.123(a)(2). Specifically, your batch production records do not indicate that your quality control operations reviewed and approved the BPRs.
 
We have reviewed your response letter dated September 13, 2017; however, we are unable to evaluate the adequacy of your intended corrective actions. In your response, you state your intent is to (b)(4) that will (b)(4); you have provided no documentation to demonstrate you have (b)(4) or that you have revised your production records to include complete information relating to the production and control of each batch.
 
5.    For each lot of packaged and labeled dietary supplements that you distribute, your firm failed to collect reserve samples and hold the samples using the same container closure system in which the packaged and labeled dietary supplements were distributed, as required by 21 CFR 111.83(b)(1). Specifically, you began collecting reserve samples since June 2017; however, your reserve samples were not held using the same container-closure system in which the packaged and labeled dietary supplement is distributed. Further, the reserve samples did not consist of at least twice the quantity necessary for all tests or examinations to determine whether, or not the dietary supplement meets product specifications, in accordance with 21 CFR 111.83(b)(4).
 
We have reviewed your response letter dated September 13, 2017. However, your response does not identify the specific corrective actions you plan to take or provide documentation that demonstrates you have started collecting and holding samples of at least twice the quantity necessary for all tests and examinations and in the same container closure system.
           
6.    You failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553. Specifically, you have not established written procedures for handling product complaints. In addition, we note you must ensure product complaints are reviewed and investigated as required by 21 CFR 111.560 and written records of every product complaint that is related to good manufacturing practice and subsequent investigations are made and kept, as required by 21 CFR 111.570(b)(2).
 
We have reviewed your response letter dated September 13, 2017. However, your response does not identify the specific corrective actions you plan to take and does not provide written documentation of your procedures for handling product complaints.
 
7.    You failed to establish and follow written procedures for your packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you do not have written procedures for your packaging and labeling operations. In establishing written procedures, such procedures must satisfy the requirements that apply to packaging and labels as specified in 21 CFR 111.410, including:
a.  You must control the issuance and use of packaging and labels and reconciliation of any issuance and use discrepancies [21 CFR 111.410(b)];
b.  You must examine, before packaging and labeling operations, packaging and labels for each batch of dietary supplement to determine whether the packaging and labels conform to the master manufacturing record [21 CFR 111.410(c)]; and
c.  You must be able to determine the complete manufacturing history and control of the packaged and labeled dietary supplement through distribution [21 CFR 111.410(d)].
 
We have reviewed your response letter dated September 13, 2017. However, your response does not identify the specific corrective actions you plan to take and does not provide written procedures for your packaging and labeling operation.
 
8.    You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have no written procedures for returned dietary supplements. Additionally, you failed to make and keep records of a material review and disposition decision on a returned dietary supplement, as required by 21 CFR 111.535(b)(2). Specifically, you stated to our investigator that you have had a few products returned, but you did not keep any records related to a material review and disposition decision on the returned dietary supplements.
 
We have reviewed your response letter dated September 13, 2017. However, your response does not identify the specific corrective actions you plan to take and does not provide written procedures for fulfilling the requirements related to returned dietary supplements.
 
9.    You failed to establish and follow written procedures for fulfilling the requirements related to equipment and utensils, including written procedures for 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 111.25(c). Specifically, you did not have any written procedures for equipment maintenance, cleaning, and sanitizing.
 
We have reviewed your response letter dated September 13, 2017. However, your response does not identify the specific corrective actions you plan to take and does not provide your written procedures for maintaining equipment and utensils.
 
Misbranded Dietary Supplements
 
The dietary supplement products discussed below are misbranded within the meaning of Section 403 [21 U.S.C. § 343] of the Act because they fail to comply with the regulations implementing the food labeling requirements of the Act for dietary supplements, found in 21 CFR Part 101. Additionally, even if your Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, and BP Formula products did not have therapeutic claims which make them unapproved new drugs and misbranded drugs, these products would be misbranded within the meaning of Section 403 of the Act for the reasons described below. 
                                                      
1.    Your Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da), S/S Complete or Staph/Strep), B-Alergone, E O Support or End O Me), EnnerLite, Cayenne, Reproductive Tonic, Prostate Formula, MommyLite, EZ Move, Hormone Balancer, and BP Formula products are misbranded within the meaning of Section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the labels fail to identify the products by using the term “dietary supplement” as a part of the product’s statement of identity, as required by 21 CFR 101.3(g).
 
2.    Your Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, and BP Formula 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 presentation of the nutrition information on the labeling of your products does not comply with 21 CFR 101.36. Specifically, your Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, and BP Formula product labels fail to present nutrition information in the form of a “Supplement Facts” panel, as required by 21 CFR 101.36.
 
3.    Your S/S Complete, Reproductive Tonic, Prostate Formula, MommyLite, EnnerLite, EZ Move, and Hormone Balancer product are misbranded within the meaning of Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the label fails to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. For example,
  • Your S/S Complete or Staph/Strep, S.G. Cough Syrup, K B Complete or Kidney/Bladder, Bac-ta-Bitters, and BP Formula product labels declare ingredients which are not appropriate common or usual names for any known ingredients, as such it is impossible for consumers to determine the ingredients in your product. Specifically, your S/S Complete or Staph/Strep product label declares the dietary ingredients Graviola and A.C. vinegar, your S.G. Cough Syrup product label declares the dietary ingredients Elder and Brigham tea, your K B Complete or Kidney/Bladder product label declares the dietary ingredients Golden Rod and Queen of Meadow, your Bac-ta-Bitters product label declares the dietary ingredient Graviola, and your BP Formula product label declares Graviola and Nettle, but these are not the common or usual names for dietary ingredients. 
4.    Your products are misbranded within the meaning of Section 403(s)(2)(A)(ii)(I) of the Act [21 U.S.C. § 343 (s)(2)(A)(ii)(I)] in that each label fails to include the quantitative amount by weight per serving size of all the dietary ingredients as required by 21 CFR 101.36.
 
5.    Your S/S Complete or Staph/Strep, S.G. Cough Syrup, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, EnnerLite, C D A Complete or Can D da, B-Alergone, Bac-ta-Bitters, and BP Formula products are misbranded within the meaning of Section 403(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 dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1). Although some of the plant parts appear to be identified, these are abbreviated and must be spelled out.
 
6.    Your Osha Root, S.G. Cough Syrup, Bac-ta-Bitters, A V Complete or Anti-Viral, K B Complete or Kidney/Bladder, C D A Complete or Can D da, S/S Complete or Staph/Strep, B-Alergone, E O Support or End O Me, EnnerLite, Cayenne, Reproductive Tonic, Prostate Formula, MommyLite, EZ Move, and Hormone Balancer, and BP Formula products are misbranded within the meaning of Section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the labels fail to declare the serving size in accordance with 21 CFR 101.9(b) and 101.36(b)(1)(i). Serving size shall be expressed in common household measures followed by the equivalent metric quantity in parenthesis.
 
7.    Your Hormone Balancer 2 fl. oz. and E O Support or End O Me products are misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the labels fail to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
 
8.    Your Hormone Balancer 2 fl. oz. and E O Support or End O Me products are misbranded within the meaning of Section 403(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) may receive a report of a serious adverse event with such dietary supplement.
 
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or in connection with your products.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations.  It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. 
 
You should take prompt action to correct or implement corrections to the violations cited in this letter.  Failure to do so may result in legal action without further notice, including, without limitation, seizure and/or injunction.
 
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken.  If your firm’s planned 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 (15) business days, state the reason for the delay and the time within which these activities will be completed.
 
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 re-inspection-related costs. A re-inspection 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. Re-inspection related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs from the responsible party for the domestic facility.
 
Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Nancy G. Schmidt, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Schmidt at (303) 236-3046 if you have any questions about this matter.
 
Sincerely,
/S/ 
LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Foods –
Division IV West