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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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The Muscadine Group, LLC 7/12/13

  

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

Public Health Service
Food and Drug Administration
 Atlanta District Office
60 8th St., NE
Atlanta, GA 30309 

 

July 12, 2013
 
 
VIA UPS
 
Rudolph C. Mullis, Jr., President
The Muscadine Group, LLC
826 Pine Level Micro Rd.
Pine Level, NC 27568
 
WARNING LETTER
(13-ATL-18)
 
Dear Mr. Mullis,
 
On September 4-5, 2012, the U.S. Food & Drug Administration (FDA) conducted an inspection of your facility located at 826 Pine Level Micro Rd., Pine Level, NC. During the inspection, the Investigator collected labeling for your “Muscadine Grape Seeds Antioxidant Vegetable Capsules” product. We have also reviewed your website used to market your product, www.muscadinegrapeseeds.com. We have determined that your product, “Muscadine Grape Seeds Antioxidant Vegetable Capsules” is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. As described further below, your marketing of this product violates sections 505(a) and 502(f)(1) of the Act [21 U.S.C. §§  355(a) and 352(f)(1)].
 
The inspection also revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements as found in Title 21 of the Code of Federal Regulations Part 111 (21 CFR Part 111). Therefore, even if your “Muscadine Grape Seeds Antioxidant Vegetable Capsules” product (which you label as a dietary supplement) were not a drug under section 201(g)(1)(B) of the Act, it would be an adulterated dietary supplement within the meaning of 402(g)(1) of the Act [21 U.S.C. § 342 (g)(1)] as described further below.
 
You can find the Act and its implementing regulations through links on FDA’s home page at http://www.fda.gov
 
During the inspection of your facility, we collected labeling for your product. In addition, in December 2012 we reviewed your website at www.muscadinegrapeseeds.com. We have determined that your “Muscadine Grape Seeds Antioxidant Vegetable Capsules” are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims made on your product labels and website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act. You were previously informed in a letter dated November 6, 2007, which you acknowledged as having received, that FDA had reviewed your website and determined that the marketing of your product with some of these same claims was in violation of the Act; yet you continue to market your product on your website with these claims. 
 
On October 1, 2012, FDA received your undated response to the Form FDA 483 Inspection Observations that the FDA Investigator issued to you following the inspection. We have determined your response is inadequate for the reasons discussed below. Your response also does not detail an estimated timeframe for completion of the corrections it discusses.   
 
Examples of some of the claims observed on the labels for your products, accompanying promotional literature, and your website include, but are not limited to, the following:
 
The product label on your product contains the following statement:
 
  • “These highly publicized phyto-nutrients have been shown to be chemo-preventive and chemo-therapeutic agents and may decrease the possibility of Heart Disease and Cancer. Muscadine Grape Seeds OXYGEN RADICAL ABSORTION [sic] CAPACITY (ORAC) is 831 u/mole TE/g. ORAC is the best measurement of an Antioxidant’s ability to neutralize harmful toxic agents called Free Radicals, which have been linked to over 60 diseases and conditions.”
 
Statements made on your website include:
 
  • “North Carolina Muscadine Grape Seeds… Scientific research has shown that there are over 60 known diseases and conditions that are linked directly to these Free Radicals. Some of these diseases and conditions include:
Allergies – Rheumatoid Arthritis – Cancer - Diabetes…Osteoporosis, Parkinson’s Disease…Birth Defects, High Blood Pressure- Heart Disease – Schizophrenia - Hardening of the Arteries – Cardiovascular Disease … Crohn’s  Disease – Alzheimer’s Disease …”
 
Your firm’s website also contains disease claims in the form of personal testimonials, including:
 
  • “This product [Muscadine Grape Seeds Antioxidant Vegetable Capsules] has lowered my Blood Pressure to the point that the Doctor has taken me off my Blood Pressure medications…And my Cholesterol actually went down too!”
  • “I have had arthritis most of my adult life. The MuscadineGrapeSeed product has really helped the inflammation that I suffer from every day.”
 
The claims listed above establish that this product is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], because it is intended for use in the cure, mitigation, treatment, or prevention of disease. This product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from the 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.
 
Furthermore, because the product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions for use cannot be written so that a layman can use the product safely for the intended uses. Thus, this product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
 
In addition, even if your “Muscadine Grape Seeds Antioxidant Vegetable Capsules” product were not an unapproved new drug and a misbranded drug, it would be an adulterated dietary supplement within the meaning of Section 402(g)(1) of the Act [21 United States Code (U.S.C.) § 342(g)(1)], in that the product was prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements in 21 CFR Part 111. 
 
During the inspection, our FDA Investigator observed the following serious violations of the CGMP regulations for dietary supplements:
 
1.      You failed to prepare and follow a written master manufacturing record (MMR) that complies with the requirements of 21 CFR 111.205. Specifically, although your document titled "Master Manufacturing Records" contains a listing of the ingredients and components to be used in the production of a batch of dietary supplement and an "Inspection Statement Concerning Incoming Raw Pomace," it does not identify specifications for the 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, as required by 21 CFR 111.205(b)(1). Your “Master Manufacturing Records” document also does not establish controls and procedures to ensure that each batch of dietary supplement that you manufacture meets these identified specifications, as required by 21 CFR 111.205(b)(2).
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response letter did not address the deficiencies listed above in your MMR document.
 
2.      Your MMR does not include the written instructions that are required by 21 CFR 111.210(h). Specifically, it does not include written instructions that set forth 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, as required by 21 CFR 111.210(h)(1); and it does not include written instructions that set forth 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 master manufacturing record, as required by 21 CFR 111.210(h)(3).
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response letter did not address the deficiencies listed above in your MMR document.
 
3.      You failed to establish component specifications and finished product specifications, as required by 21 CFR 111.70. You also failed to comply with the requirements in 21 CFR 111.75 to ensure that these established specifications are met, and you failed to comply with requirement in 21 CFR 111.303 that you establish and follow written procedures for the tests and examinations that you conduct to determine whether these established specifications are met. Specifically:
 
  • You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient (specifically, the muscadine grape pomace), prior to its use. 21 CFR 111.75(a)(l)(i) requires at least one such test or examination unless you petition the agency and receive an exemption under 111.75(a)(1)(ii), which you did not do.  21 CFR 111.303 further requires that you establish and follow written procedures for this test or examination, which you did not do. You also failed to establish an identity specification for each component that you use in the manufacture of your dietary supplement, as required by 21 CFR 111.70(b)(1), which you must do before you can verify that such specification is met.
  • You failed to establish 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, as required by 21 CFR 111.70(e). You also failed to verify that your finished batch of the dietary supplement meets these product specifications for identity, purity, strength, composition, 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, which 21 CFR 111.75(c) requires you to do for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan (or for every finished batch). Furthermore, you failed to establish and follow written procedures for the tests and examinations that you conduct to verify that your finished batch meets these established product specifications, as required by 21 CFR 111.303.
 
We have reviewed your undated response letter, and have determined your response to be partially adequate. Your response provides a table titled "Checklist for Quality Control of Finished Product Specs" which contains some acceptance criteria for the finished product.  However, your response does not specify the analytical tests used to determine these acceptance criteria.  Your response provides an SOP which lists using HPLC to test an extract of Muscadine Grape Seeds for various components e.g., (b)(4). However, the HPLC method is not provided, nor did you provide written procedures for this test. In addition, you did not provide documentation demonstrating that for a subset of finished batches that you identified through a sound statistical sampling plan (or for every finished batch), the finished product was tested to meet these acceptance criteria (to verify that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, composition and for limits on those types of contamination that may adulterate or that may lead to adulteration). Moreover, your response does not address the other violations listed above.
 
4.      You failed to implement a system of production and process controls that covers all stages of manufacturing, packaging, labeling, and holding of the dietary supplement 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 111.55.
 
We have reviewed your undated response letter, and have determined your response to be inadequate.  For example, with respect to the design requirements for your production and process control system, your response includes an SOP entitled “In-Process Control System for Muscadine Capsules.” This SOP states, among other things, “Periodically, sample raw materials as they are being processed in order to assure [sic] the quality of the components and finished product.” However, you did not define “periodically.” Specifically, you do not state how often the raw materials are to be sampled. Furthermore, this SOP states, “Record all pertinent values of Raw Pomace, including (b)(4), etc.” However, you did not provide acceptable ranges for these values. Your response also does not specify what action should be taken if any of these values falls outside the acceptable range of values.
 
5.      You failed to identify who is responsible for your quality control operations, as required by 21 CFR 111.12(b). Under that provision, 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.
 
We have reviewed your undated response letter, and have determined your response to be partially adequate. Your response provides the names of the members of the quality control unit. However, you have not provided information that would allow us to evaluate whether you are complying with the requirement under 21 CR 111.12(b) that these persons be qualified to perform quality control operations and that they have distinct and separate responsibilities related to those operations.
 
6.      Your batch production records (BPRs) do not include complete information relating to the production and control of each batch as required by 21 CFR 111.255(b). Specifically, we reviewed your BPRs for batches #910-1C, 810-1C, 711-1C, and 312-1C of your Muscadine Grape Seeds Antioxidant Vegetable Capsules. These BPRs do not include the following elements that are required by 21 CFR 111.260:
 
  • 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 (see 21 CFR 111.260(c));
  • The actual results obtained during any monitoring operation (see 21 CFR 111.260(g));
  • The results of any testing or examination performed during the batch production, or a cross-reference to such results (see 21 CFR 111.260(h));
  • Documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g) (see 21 CFR 111.260(i); as is discussed elsewhere in this letter, you failed to establish specifications in accordance with 21 CFR 111.70(e) and (g));
  • Documentation, at the time of performance, of the manufacture of the batch (see 21 CFR 111.260(j)), including the initials of the person responsible for weighing or measuring each component used in the batch (see 21 CFR 111.260(j)(2)(i)) and the initials of the person responsible for verifying the addition of components to the batch (see 21 CFR 111.260(j)(2)(iv)); and
  • Documentation, at the time of performance, of packaging and labeling operations (see 21 CFR 111.260(k)), including the unique identifier that you assigned to packaging and labels used and the quantity of the packaging and labels used (see 21 CFR 111.260(k)(1)); 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 (see 21 CFR 111.260(k)(2)); and the results of any tests or examinations conducted on packaged and labeled dietary supplements, or a cross-reference to the physical location of such results (see 21 CFR 111.260(k)(3)).
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response includes a document titled "Batch Control Check List (for Batch Production Record)" with the subheading "concerning Raw Pomace," and another document titled "Checklist for Quality Control of Finished Product Specs." These documents do not include complete information relating to the production and control of a batch. For example, these documents do not address maintenance, cleaning, and sanitation of equipment and processing lines, and they do not contain the actual results obtained during monitoring operations or the results of any testing or examination performed during the batch production (or a cross-reference to such results). Moreover, with respect to the requirement to document that the finished dietary supplement meets specifications established in accordance with 21 CFR 111.70(e) and (g), we note that your failure to fully comply with 21 CFR 111.70(e) and (g) is reflected in these documents. For example, the Batch Control Check List includes a visual examination with instructions to remove foreign objects such as insects, stem, or debris before grinding any materials. However, you do not specify the limit, if any, of the number of foreign objects allowed in the raw Pomace. Furthermore, the Checklist for Quality Control of Finished Product Specs indicates that the Muscadine Grape Seeds should be “finely ground”; but you do not provide specifications for that term.
 
7.      You failed to quarantine components before using them in the manufacture of your Muscadine Grape Seeds Antioxidant Vegetable Capsules, as required by 21 CFR 111.155(c). Specifically, you acknowledged that components are not quarantined prior to use.
 
We note that under 21 CFR 111.155(c) you must quarantine components before you use them in the manufacture of a dietary supplement until:
 
(1) You collect representative samples of each unique lot of components (and, for components that you receive, of each unique shipment, and of each unique lot within each unique shipment);
(2) Quality control personnel review and approve the results of any tests or examinations conducted on components; and
(3) Quality control personnel approve the components for use in the manufacture of a dietary supplement, including approval of any treatment (including in-process adjustments) of components to make them suitable for use in the manufacture of a dietary supplement, and releases them from quarantine.
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response contains a quarantine checklist that indicates that a manager is to initial each item after “inspection and approval.” However, this checklist does not state what that inspection and approval process entails. Your response does not indicate that you are collecting representative samples of each unique lot of components, nor does it indicate the tests or examinations that the quality control personnel are required to review.
 
8.      You failed to comply with the requirements of Subpart M of 21 CFR Part 111, which relate to your holding and distributing operations. Specifically,
 
  • You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Among other things, such written procedures should address the holding of dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the dietary supplements are not affected, as required by 21 CFR 111.455(a). 
  • You failed to identify and hold in-process material under conditions that protect against mixup, as required by 21 CFR 111.460(a). Specifically, the investigator observed unidentified drums containing bulk ground grape seeds being stored in the "Pomace Blending Area."
  • You failed to hold your reserve samples using the same container-closure system in which the packaged and labeled dietary supplement is distributed, as required by 21 CFR 111.465(a)(2). Specifically, your reserve samples are held in the Lab area of the Pine Level facility and the white bottles containing reserve samples are not safety shrink sealed in the same manner as the distributed finished packaged products.
  • Additionally, you failed to make and keep the records required under subpart M of 21 CFR Part 111 in accordance with subpart P of 21 CFR Part 111, as required by 21 CFR 111.475(a). Specifically, you failed to make and keep distribution records.
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Though your response includes an SOP entitled “Holding and Sampling of Muscadine Capsules,” the written procedures in this SOP do not address all of the elements of your holding and distributing operations. We also note that your process requirement to "store samples in the ENCAPSULATION room where no air, light, or heat is present" is either imprecisely written or impractical.  Furthermore, your response did not include documentation that would allow FDA to establish if you have corrected the above-listed violations of 21 CFR 111.460(a), 21 CFR 111.465(a)(2), and 21 CFR 111.475(a).
 
9.      You failed to comply with the requirements for reserve samples that are established by 21 CFR 111.83. Specifically, for each lot of packaged and labeled dietary supplements that you have distributed, your firm has not held the reserve samples using the same container closure system in which the packaged and labeled dietary supplement is of at least twice the quantity necessary for all tests or examinations to determine distributed as required by 21 CFR 111.83(b)(l). Your reserve samples also do not consist whether or not the dietary supplement meets product specifications as required by 21 CFR 111.83(b)(4).
 
We have reviewed your undated response letter, and have determined your response to be partially adequate. Your response provides an SOP which includes instruction to hold samples in dark amber glassware in a "Clean Room with no light, heat, etc." This portion of the response is inadequate because it does not make clear whether you are holding the reserve samples using the same container-closure system in which the packaged and labeled dietary supplement is distributed. You also state that a "minimum of (b)(4) should be stored from each LOT#". However, your response did not indicate that you had established the quantity necessary of reserve sample in order to conduct all tests or examinations to determine whether or not the dietary supplement meets product specifications. We were therefore unable to evaluate whether or (b)(4) is twice the quantity necessary to conduct those tests or examinations, as required by 21 CFR 111.83(b)(4).
 
10.      You failed to establish specifications for the packaging and labeling of the finished packaged and labeled Muscadine Grape Seeds Antioxidant Vegetable Capsules, including specifications that ensure that you used the specified packaging and that you applied the specified label, as required by 21 CFR 111.70(g).
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response includes a document entitled “Packaging SOP,” but this document does not establish specifications for packaging and labeling.
 
11.      Your firm failed to make and keep written procedures for fulfilling the requirements of subpart B of 21 CFR Part 111, as required by 21 CFR 111.14(b)(1). Specifically, you acknowledged to our investigator that you do not have procedures to fulfill the following requirements of subpart B that relate to hygienic practices and to preventing microbial contamination from sick or infected personnel:
 
  • Excluding from working in any operations that may result in contamination any person who, by medical examination, the person's acknowledgement, or supervisory observation, is shown to have, or appears to have, an illness, infection, open lesion, or any other abnormal source of microbial contamination, that could result in microbial contamination of components, dietary supplements, or contact surfaces, until the health condition no longer exists (21 CFR 111.10(a)(1)).
  • Using hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces, as required by 21 CFR 111.10(b). These hygienic practices include the following:
o   Wearing outer garments in a manner that protects against the contamination of components, dietary supplements, or any contact surface (21 CFR 111.10(b)(1));
o   Maintaining adequate personal cleanliness (21 CFR 111.10(b)(2));
o   Washing hands thoroughly (and sanitizing if necessary to protect against contamination with microorganisms) in an adequate hand-washing facility:
  • Before starting work; and
  • At any time when the hands may have become soiled or contaminated (21 CFR 111.10(b)(3));
o   Removing all unsecured jewelry and other objects that might fall into components, dietary supplements, equipment, or packaging, and removing hand jewelry that cannot be adequately sanitized during periods in which components or dietary supplements are manipulated by hand. If hand jewelry cannot be removed, it must be covered by material that is maintained in an intact, clean, and sanitary condition and that effectively protects against contamination of components, dietary supplements, or contact surfaces (21 CFR 111.10(b)(4);
o   Maintaining gloves used in handling components or dietary supplements in an intact, clean, and sanitary condition. The gloves must be of an impermeable material (21 CFR 111.10(b)(5));
o   Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other effective hair restraints (21 CFR 111.10(b)(6));
o   Not storing clothing or other personal belongings in areas where components, dietary supplements, or any contact surfaces are exposed or where contact surfaces are washed (21 CFR 111.10(b)(7));
o   Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed (21 CFR 111.10(b)(8)); and
o   Taking any other precautions necessary to protect against the contamination of components, dietary supplements, or contact surfaces with microorganisms, filth, or any other extraneous materials, including perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin (21 CFR 111.10(b)(9)).
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your state that "all employees will be trained in food safety and personal hygiene and will be provided with a brochure of food safety requirements (worker hygiene training content and brochure located in Appendix II).” However, Appendix II is not provided. Therefore we were unable to evaluate the adequacy of your brochure.
 
In addition, you state that "Workers with intestinal illness or infectious disease (diarrheal symptoms) should not be allowed to work in contact with fresh produce and should be assigned other duties when appropriate." This statement is inadequate. Workers with an intestinal illness must be excluded from any operations that may result in contamination of any material, including components, dietary supplements, and contact surfaces used in the manufacture, packaging, labeling, or holding of a dietary supplement.
 
12.      Your firm failed to establish written procedures to fulfill the requirements of 21 CFR 111.560 (which relate to the review and investigation of product complaints), as required by 21 CFR 111.553. Specifically, you acknowledged to our investigator that you did not have written procedures for the handling of product complaints regarding Muscadine Grape Seeds Antioxidant Vegetable Capsules that you distribute and for adequately investigating complaints.
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response deals with return procedures, however, the procedures are not provided. Your response does not address product complaints.
 
13.      Your firm failed to establish and follow written procedures for fulfilling the requirements for returned dietary supplements, as required by 21 CFR 111.503. Specifically,
 
  • You did not have procedures to fulfill the requirement in 21 CFR 111.510 that you identify and quarantine returned dietary supplements until quality control personnel conduct a material review and make a disposition decision.
  • You did not have written procedures for handling any returned dietary supplements, including when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520, or when a returned dietary supplement must be destroyed or otherwise suitably disposed of in accordance with 21 CFR 111.515.
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response is a standard operating procedure that states, in part, “Destroy all returned product and packaging according to guidelines for disposal.” However, we have not received a copy of the referenced guidelines. Hence, we were unable to evaluate the adequacy of those guidelines.
 
14.      You failed to identify each unique lot within each unique shipment of components that you receive in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement that you manufactured and distributed, as required by 21 CFR 111.155(d)(l). Specifically, you failed to document the receipt, storage, and use of any of the components you received and utilized for the manufacture of Muscadine Grape Seeds Antioxidant Vegetable Capsules.
 
We have reviewed your undated response letter, and have determined your response to be inadequate. Your response provides an SOP that does not specify how you will identify each unique lot within a unique shipment of components that you received in a manner that allows you to trace the lot to the supplier.
 
This letter is not intended to be an all-inclusive list of the violations that may exist at your facility and with your products, labels, and labeling. It also does not indicate that FDA has conducted an all-inclusive review of all the products you manufacture and distribute. It is your responsibility to ensure the products you manufacture and distribute are in compliance with all applicable statutes and regulations, including the Act, the CGMP regulations for dietary supplements (21 CFR Part 111), and all applicable FDA labeling regulations.
 
You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA taking regulatory action, such as seizure or injunction, without further notice.
 
In addition, we also offer the following comment:
 
In response to the FDA Investigator’s observation on Form FDA 483 that the expiration date specified on your product label is not based on appropriate stability studies, your undated response letter states that “the twelve month shelf life has been removed from any future labels and the only number of information that will be printed on each new label will be the lot number.”  This response is adequate. Please note that any expiration date, shelf life date, or “best if used by” date you place on a product label should be supported by data [see 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
 
You should notify this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. In your response, please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections.
 
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 determining 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Your written response should be sent to the U.S. Food and Drug Administration, Attn: Janice L. King, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. King at 843-746-2990 or write her at the noted address. 
 
Sincerely,
/S/
John R. Gridley
District Director
Atlanta District Office
 
Cc: Robert W. Hinnant, Jr., Co-Owner