MMR issues incomplete Batch Production Records, no written procedures for weighing and blending, no written procedures for quality control operations. If this company does not respond adequately and execute on its promises, it would appear to be a prime candidate of FDA's next injunction action.
Food for Health International, LLC 10/5/12
Department of Health and Human Services
Public Health Service
Food and Drug Administration
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
October 5, 2012
Mr. Frank L. Davis, Chief Operating Officer
Food for Health International, LLC.
4626 North 300 West #350
Provo, Utah 84604
Dear Mr. Davis:
On April 12, 13, 16, 18, and May 4, 2012, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 3560 West Ninigret Drive, Salt Lake City, Utah. Our investigators found a number of violations of the Current Good manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause the dietary supplement products manufactured in your facility, 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 these dietary supplements have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
In addition, based on our review of the labeling for your Activz Control product, including your website www.foodforhealthinternational.com, we have determined that this product is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims in your labeling 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 your product with these claims violates the Act. You can find the Act and its implementing regulations through links on FDA’s home page at www.fda.gov.
Unapproved New Drug:
Your product label and website, www.foodforhealthinternational.com, promote your Activz Control product for conditions that cause the product to be a drug under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)]. The therapeutic claims in your labeling for this product establish that this product is a drug because it is intended for use in the cure, mitigation, treatment or prevention of disease. Examples of some of the claims observed in the labeling for your product include:
Activz Control – product label
- “[P]romotes blood sugar balance”
- “Activz control assists the body by . . . Reducing Bad Cholesterol . . . Decreasing hypertension”
Activz Control – product webpage
- “Avoid blood sugar spikes with a unique blend of phytonutrients . . . that help your body stabilize blood sugar levels . . . .”
- “Our proprietary ingredients are so gentle that anyone will benefit, including both hypoglycemic and hyperglycemic individuals.”
- “Contains . . . antioxidants to fight free radicals that cause . . . disease.”
- “Innovative formula . . . to help body stabilize blood sugar . . . .”
Your Activz Control 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)]. 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 Activz Control product is 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 product’s intended uses, causing the product 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)].
Even if your Activz Control product did not contain claims in its labeling that cause it to be a drug, it would still be an adulterated dietary supplement, based on the violations for the dietary supplement products you manufacture.
Adulterated Dietary Supplements
The inspection revealed the following violations of the CGMP requirements for dietary supplements:
1. You failed to establish the specifications required under 21 CFR 111.70, as follows:
· You failed to establish specifications for a point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR) [21 CFR 111.70(a)].
· You failed to establish component specifications for each component that you use in the manufacture of a dietary supplement that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, and to establish 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)(2) and (3)].
· You failed to establish specifications for dietary supplements labels and for packaging that may come in contact with dietary supplements [21 CFR 111.70(d)].
· 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 [21 CFR 111.70(e)].
Specifically, you only conduct identity testing on raw materials and microbial and heavy metal testing for finished products. You do not have other specifications for your raw material. Although you conduct microbiological and heavy metal testing on your finished products, you have not established acceptable limits; only pass/fail results.
We have reviewed your response that we received on May 16, 2012, and determined it is inadequate. You provided a target date of June 29, 2012 for establishing controls for printed materials. Your response did not include any documentation that you have created the specifications noted as missing above, nor did you address your plans for product manufactured and/or marketed while corrections were being implemented.
2. The regulations allow for supplier (vendor) qualification to confirm the identity of components, other than dietary ingredients, and the use of certificates of analysis (COA) after qualification of the supplier (21 CFR 111.75(a)(2)(ii)). Supplier qualification only applies to components (excluding dietary ingredients) used in the manufacture of dietary supplements. However, you failed to qualify a supplier of such a component by establishing the reliability of the supplier’s COA through confirmation of the results of their tests or examinations, as required by 21 CFR 111.75(a)(2)(ii)(A). Your firm releases raw materials for use in manufacturing based on the COA. Although you have a written operating procedure “Supplier Certification Process” for random testing to qualify a vendor, you do not conduct or send raw material components for testing to qualify the raw mate rial suppliers’ COAs.
Your written response is inadequate. You stated that raw material specifications will be created and training will be provided to applicable departments by the target completion date of September 28, 2012. However, you did not include documentation that you have implemented your qualification process such as random testing of the results for COAs, required information from your vendors, information about the methods you will use to qualify your vendors, or your plans for product manufactured and/or marketed while corrections are being implemented.
3. You failed to prepare a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and each batch size, to ensure, uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a). Specifically, you have not established written MMRs for the following Activz brand name products: Vitamin D, Potassium Iodine, Organic Vitamin C, Whole 9, Control, and VMA .
We have reviewed your response and determined it is inadequate. You stated that you will create a MMR by August 31, 2012. Your response did not include any documentation that you are in the process of establishing written master records to ensure uniformity in the finished batch. It does not address whether you will continue to make dietary supplements before you have established MMRs.
4. You failed to include required information in your batch production records (BPR) for your Activz VMA (b)(4)and Control (b)(4) products, as required by 21 CFR 111.260. Specifically, your BPRs failed to include the following information:
· the identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)];
· 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)];
· 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)];
· the actual results obtained during any monitoring operation (e.g., drying, filling) [21 CFR 111.260(g)];
· the results of any testing or examination performed during the batch production, or cross-reference to such results [21 CFR 111.260(h)];
· documentation that the finished dietary supplement meets specifications established in accordance with 21 CFR sections 111.70(e) and (g) [21 CFR 111.260(i)];
· 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)];
· 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)];
· documentation, at the time of performance, that quality control personnel reviewed the BPR [21 CFR 111.260(l)(1)]; and
· documentation at the time of performance of any required material review and disposition decision [21 CFR 111.260(m)].
During the inspection your Quality Assurance Manager stated that a new set of batch records with a cover sheet was being developed that would allow employees to verify each step, and sign the bottom indicating the entire batch record was reviewed and qualified for release and distribution. The new documentation system has not been established or implemented. Your firm continues to use an incomplete batch record that is deficient.
Your sole response, received on May 16, 2012, is inadequate. Although you discussed the batch record requirements in your response, you did not provide any documentation of corrections regarding these requirements. You list July 31, 2012 for the completion date of the batch record requirements.
5. You did not establish written procedures for manufacturing operations, as required by 21 CFR 111.353. Specifically, you do not have written procedures for weighing and blending of dietary supplements. When our investigator asked how employees know how long to blend different powders, your Supplement Supervisor responded that the employees are verbally provided the time needed for blending different powders. However, without written procedures, there is no assurance that the dietary supplement products are consistently manufactured to meet specifications. You are also required to make and keep records of your written procedures for manufacturing operations [21 CFR 111.375(b)].
Your written response is inadequate because you did not include any written procedures for the weighing and blending of your dietary supplements for our review. You stated that you will create procedures and provide training to applicable departments. You provided a target completion date of July 31, 2012.
6. You did not establish written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Specifically, you have a label cage and labels are issued to the line in your computer which reconciles the labels as they come in. All this information is in the computer; however, there is no written procedure for how labels are received in the cage, their issuance to the line, or for reconciliation when they are returned to the cage. You are also required to make and keep records of the written procedures for packaging and labeling operations [21 CFR 111.430(b)].
We have determined that your written response is inadequate. You stated that you will create procedures and provide training to applicable departments, and provided a target completion date of July 31, 2012. However, your written response is inadequate because you did not include a written procedure for the control and reconciliation of your labels issued to the line and failed to include your plans for product manufactured and/or marketed while corrections are being implemented.
7. You failed to establish written procedures for the responsibilities of the quality control operations, as required by 21 CFR 111.103. You do not have written procedures for the responsibilities of your quality control operations pertaining to the following areas:
· Laboratory operations [21 CFR 111.110]
· Representative samples and reserve samples [21 CFR 111.105(f) and (g)]
· Material review and disposition [21 CFR 111.113]
· Equipment, instruments and controls [21 CFR 111.117]
· Components, packaging and labeling [21 CFR 111.120]
· Master manufacturing batch production records and manufacturing operations [21 CFR 111.123]
· Reprocessing [21 CFR 111.130(d)]
· Returned dietary supplements [21 CFR 111.130]
· Release of packaged and labeled dietary supplements [21 CFR 111.123(a)(8)]
Your written response is inadequate. You stated that various processes have been reviewed and that procedures will be written. Your response did not include any of the written procedures that were noted above as missing, nor did you address your plans for product manufactured and/or marketed while corrections are being implemented.
8. Your quality control operations for product complaints do not include reviewing and approving decisions about whether to investigate a product complaint; and reviewing and approving the findings and follow-up action of any investigation performed, as required by 21 CFR 111.135 and 21 CFR 111.560. Specifically, your quality assurance department did not have access to the consumer complaint program nor were they included in the review of consumer complaints to determine if an investigation was to be conducted. The quality assurance department has a current consumer complaint procedure that explains that all complaints should be routed through the Quality Assurance Manager who is supposed to determine the response to complaints. It also indicates that quality assurance will evaluate the complaints, record findings, recommend product recalls and place product on hold. Instead, your firm&rs quo;s complaints are handled by the customer service department that is separate from the quality assurance department.
Your written response is inadequate. You stated that your quality assurance department will gain access to and have the ability to review all customer related complaints, and you provided a target completion date of July 31, 2012. However, you did not provide any documentation that your quality control operations is now performing its duties with regard to product complaints.
9. You did not establish written procedures for fulfilling the requirements for equipment and utensils, as required by 21 CFR 111.25 for (a) Calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement; (b) Calibrating, inspecting and checking automated, mechanical and electronic equipment; and (c) Maintaining, cleaning and sanitizing, as necessary, all equipment, utensils and other contact surfaces that are used to manufacture, package, label, or hold components or dietary supplements. Furthermore, you do not routinely calibrate, inspect, or check equipment to ensure proper performance, as required by 21 CFR 111.30(c). Specifically:
· A calibration program has not been established.
· Monitoring of the encapsulation equipment is not documented.
· There is no written procedure for running the encapsulation machine, and there are no written logs of adjustments or maintenance that is conducted on the machine.
· During the inspection, the machine that creates the foil packages was not sealing the packages correctly and was not placing an adequate notch in the side of the package. Currently there are no written procedures explaining how to operate the packaging machines.
· There are no written procedures for equipment and utensil cleaning and sanitizing operations.
We have determined that your written response is inadequate. You stated that you will create procedures and provide training to applicable departments. However, you did not indicate that you calibrated the above-referenced equipment, and you did not provide any written procedures for our review.
10. You did not make and keep documentation for the training of your employees, as required by 21 CFR 111.14(b)(2). Specifically, although your employees receive (b)(4) GMP training and the attendees’ names are recorded, there are no records for on-the-job or specialized training for manufacturing employees.
Your written response is inadequate. You did not provide any documentation that that you are now maintaining the documentation noted as missing above. You have provided a target completion date of August 31, 2012.
This letter is not intended to be an all-inclusive list of violations. It is your responsibility to ensure that your establishment and the products you market comply with the Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
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.
Please advise this office in writing within 15 days from your receipt of this letter of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, state the reason for the delay and the date by which you will complete the corrections.
LaTonya M. Mitchell
Denver District Director