Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm436442.htm
Timestamp: 2019-04-22 10:36:26+00:00

Document:
From June 3 through June 5, 2014, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 707 Greenwood Road in West Columbia, SC. Based on the inspection and review of the product labels you provided during the inspection, we have found 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.
Based on our review of your products’ labeling, we have determined that several of your firm’s dietary supplements are being promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 United States Code (U.S.C.) § 321(g)(1)(B)]. The claims made on your products’ labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331 (d)]. 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, your Sulfur Concentrate, 128 ounce and 32 ounce; Extra Strength Copper, 32 ounce; Copper, 32 ounce and 2 ounce; Extra Strength Magnesium, 32 ounce; Extra Strength Silver, 32 ounce; Silver, 32 ounce; Platinum, 32 ounce; Extra Strength Zinc, 32 ounce; Zinc, 32 ounce; Chromium, 32 ounce and 2 ounce; Indium, 32 ounce; Sodium, 2 ounce; Cesium, 2 ounce; Calcium Concentrate, 32 ounce; Extra Strength Calcium Concentrate, 32 ounce; and B6 & B12 Folic Acid, 4 ounce, 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 drugs safely for their intended purposes. Thus, these drugs are 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 a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. § 331(a)].
In addition, even if your products were not labeled for conditions that cause them to be unapproved new and misbranded drugs, your products would be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulation for dietary supplements found in Title 21 Code of Federal Regulations, Part 111 (21 CFR 111). At the close of our inspection, you were advised of these issues in the issued Form FD-483, Inspectional Observations.
1 You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and specifications 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). Specifically, you told our investigator that you manufacture the finished product strength of your products to the value declared on the label for the active ingredient; however, you do not have written finished product specifications for each dietary supplement you manufacture for identity, purity, and composition. Once you establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and specifications for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, it is your responsibility to ensure that your product meets these specifications (21 CFR 111.73).
2 You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, as required by 21 CFR 111.205(a). Specifically, when our investigator asked your firm for master manufacturing records, you stated that you do not have them. In addition, we note that an MMR must include certain information, as specified in 21 CFR 111.210.
3. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(a). Specifically, you verbally confirmed to our investigator that you did not maintain batch production records. In addition, we note that a batch production record must include certain information, as specified in 21 CFR 111.260.
4. 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, you verbally confirmed to our investigator that you did not maintain these procedures. Moreover, our investigator observed that records, including but not limited to, your production records and ingredient receiving records, do not have a QC review signature on them, as required by 21 CFR 111.105.
5. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). Specifically, you verbally confirmed to our investigator that you do not collect and hold reserve samples for each lot of packaged and labeled dietary supplements that you distribute. In addition we note that reserve samples must be maintained in accordance with certain criteria, as specified in 21 CFR 111.83(b).
6. You failed to identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce 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 you manufactured and distributed, as required by 21 CFR 111.155(d)(1). Specifically, you verbally confirmed that you do not record any kind of unique lot identified for incoming components nor the lot number assigned by the supplier of the components. Further you confirmed that you have no means to identify which specific lot of component was used to manufacture any specific lot of finished product. In addition, we note that you must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of components that you receive and any lot of components that you produce, as required by 21 CFR 111.155(d)(2).
7. You failed to identify each unique lot within each unique shipment of packaging and labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging and label, the status of the packaging and label (e.g., quarantined, approved, or rejected); and to the dietary supplement that you distributed, as required by 21 CFR 111.160(d)(1). Specifically, you verbally confirmed that you do not record any kind of unique lot identified for incoming components nor the lot number assigned by the supplier of the components. Further you confirmed that you have no means to identify which specific lot of component was used to manufacture any specific lot of finished product. In addition, we note that you must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of packaging and labels, as required by 21 CFR 111.160(d)(2).
8. You failed to establish and follow 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 111.303. Specifically, you verbally confirmed that you test every batch of product produced using an atomic (b)(4) with the results compared to a standard. However, you stated that the procedure used to perform this test is not a written procedure.
At the close of the inspection, you indicated that you would provide a written response to the FORM FDA 483, Inspectional Observations, issued to you. To date, we have not received that written response.
In addition, your Ultimate Germanium Concentrate, 2 ounce, and Germanium Concentrate, 32 ounce, dietary supplements are adulterated within the meaning of Section 402(a)(1) [21 U.S. C.§ 342(a)(1) of the Act in that they bear or contain a poisonous or deleterious substance which may render these products injurious to health. Germanium is a nonessential trace element that has caused nephrotoxicity (kidney injury) and death when used chronically by humans, even at recommended levels of use. Due to the risk of illness or injury associated with germanium, we recommend that your firm cease the manufacture and marketing of your product containing this ingredient.
· Your Extra Strength Calcium Concentrate (32 ounce) label lists the level of Chloride in the product as 184 mg and shows that the Chloride ingredient is at 6800 ppm (or 6.79 mg/ml). For a serving size of 15 ml, this results in a level of about 102 mg/serving.
· Your Extra Strength Silver Concentrate (32 ounce) label lists the level of Nitrates in the product as 0.260 mg and shows that the Nitrate ingredient is at 400ppm (or 0.4 mg/ml). For a serving size of 5 ml, this results in a level of 2 mg/serving.
2. Your Sulfur Concentrate (128 ounces and 32 ounce), Extra Strength Calcium Concentrate (32 ounce), Calcium Concentrate (32 ounce), Ultimate Calcium Concentrate (2 ounce), Extra Strength Copper Concentrate (32 ounce), Copper Concentrate (32 ounce), Ultimate Copper Concentrate (2 ounce), Extra Strength Magnesium Concentrate (32 ounce), Ultimate Magnesium Concentrate (2 ounce), Extra Strength Silver Concentrate (32 ounce), Silver Concentrate (32 ounce), Platinum Concentrate (32 ounce), and Gold Concentrate (32 ounce) 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 labels of these products fail to comply with 21 CFR 101.36(b)(2)(i). Specifically, these products declare (b)(2)-dietary ingredients, such as Calories, Total Fat and Total Carbohydrates, as zero when these (b)(2)-dietary ingredients must not be declared on the label when they are not present or are present in amounts that can be declared as zero under 21 CFR 101.9(c).
This letter is not intended to be an all-inclusive list of violations that may exist at your facility. It is your responsibility to ensure that the products you manufacture are in compliance with all requirements of the Act and pertinent FDA regulations, such as the dietary supplement regulations (21 CFR Part 111). You can find copies of the Act and pertinent regulations through links on FDA’s homepage at www.fda.gov. 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.
· You do not collect any representative samples from each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet established specifications, as required by 21 CFR 111.80(a). These samples are not required to be maintained once testing is complete, but they must be collected from each unique lot of components, packaging, and labels which you receive.
· The label for your Sulfur Concentrate, (128 ounces and 32 ounce) lists Chloride with a value of zero. This is a voluntary nutrient for declaration under 21 CFR 101.9(c)(8)(ii), and therefore, can be omitted if it is not present in the product.
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 respond to 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. 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.

References: § 321
 § 321
 § 355
 § 331
 § 352
 § 331
 § 342