Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm340194.htm
Timestamp: 2019-04-23 21:56:06+00:00

Document:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing, repacking, labeling, and distribution facility, located at 8725 Remmet Ave., Unit B, Canoga Park, CA 91304, California from July 26-31, 2012. The inspection revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements found in Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products 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 they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements.
In addition, our Investigators collected and reviewed samples of the labeling of your products during the inspection of your facility. Based on our review of the labeling of your products, we have concluded that certain of your products are in violation of section 403 and 505(a) of the Act [21 U.S.C. §§ 343 and 355(a)] and the regulations implementing the requirements of the Act, which are found in 21 CFR Part 101.
You can find the Act and its implementing regulations through links in FDA's homepage at www.fda.gov.
1. You failed to conduct at least one appropriate test or examination to verify the identity of a component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), and you have not petitioned FDA under 21 CFR 111.75(a)(1)(ii) for an exemption from this requirement. Specifically, your firm used “Niacinamide (B-3), Inositol, and Pyridoxine HCL (B-6)” to manufacture “SUPER B,” but you did not perform an identity test or examination of these dietary ingredients prior to manufacturing this product.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. You stated that you have instituted a testing procedure and are awaiting results from a third party laboratory. However, you did not provide a copy of the procedure and you did not provide any identity testing results for these dietary ingredients to demonstrate the adequacy of this corrective action. We will verify this corrective action during our next inspection.
2. You failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, you failed to establish component specifications for each component that you use in the manufacture of your dietary supplements. Specifically, our Investigator determined that you did not establish component specifications for Niacinamide USP, Pyridoxine HCL USP, and Inositol Powder.
Further, your firm failed to establish specifications to provide sufficient assurance that products your firm receives from a supplier for packaging and/or labeling and distribution as dietary supplements are adequately identified and are consistent with your purchase order, as required by 21 CFR 111.70(f). Specifically, your firm did not establish specifications for the products SUPER MSM (Methyl-Sulfonyl-Methane) 1000mg, Inositol 500mg, and White Crystalline Powder Caffeine (1/2 oz.) your firm receives in bulk for repackaging and labeling as dietary supplements.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. Your response states that your specification for your products is “100% pure.” Your response does not list any specific component specifications or product specifications for our review.
3. You rely on certificates of analysis from the suppliers of the components that you receive to determine whether component specifications established in accordance with 21 CFR 111.70(b) are met, but you failed to qualify the suppliers of components by establishing the reliability of the suppliers’ certificates of analysis through confirmation of the results of the suppliers’ tests or examinations, before using those components, as required by 21 CFR 111.75(a)(2)(ii)(A), and failed to maintain documentation of how the supplier was qualified, as required by 21 CFR 111.75(a)(2)(ii)(C). Under 21 CFR 111.75(a)(2), a certificate of analysis may be relied upon to determine whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met. In order to rely on a certificate of analysis from a supplier of the component, the following requirements of 21 CFR 111.75(a)(2)(ii) must be met: (A) qualify the supplier by establishing the reliability of the supplier’s certificate of analysis through confirmation of the results of the supplier’s tests or examinations; (B) the certificate of analysis must include a description of the test or examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations; (C) maintain documentation of how the supplier was qualified; (D) periodically re-confirm the supplier’s certificate of analysis; and (E) the documentation setting forth the basis for qualification (and re-qualification) of any supplier must be reviewed and approved by quality control personnel. Specifically, your firm relies upon certificates of analysis (COAs) from (b)(6) for Niacinamide USP, BI Nutraceuticals for Pyridoxine USP Inositol Powder, and Caffeine Anhydrous USP Powder to determine whether component specifications have been met. These certificates of analysis list specifications for purity and composition, but you failed to qualify these suppliers of components prior to using the COAs listing these specifications.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. You indicated since you purchase only pure ingredients and you test for “product id,” you feel your suppliers’ C of A are reliable. However, your firm provided no evidence that you had qualified the suppliers of these components by establishing the reliability of the certificate of analysis through confirmation of the results of the suppliers’ tests or examinations to use component specifications other than the identity specification.
4. You failed to establish and follow laboratory control processes that are reviewed and approved by quality control personnel for the use of sampling plans for obtaining representative samples, as required by 21 CFR 111.315(b). Specifically, you have no processes for the use of sampling plans for obtaining representative samples of your components, packaging, labels, and products that you receive for packaging or labeling as a dietary supplement for distribution.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. You indicated that you will sample each lot of “incoming material” and “bottled product” and save those samples. However, you did not provide any sampling plans or evidence of implementation of these plans. You also did not indicate whether you would sample components, packaging, labels, or products that you receive for packaging or labeling as a dietary supplement.
5. You failed to approve, and release from quarantine, all components, packaging, and labels before they were used, as required by 21 CFR 111.120(e).
Specifically, your quality control operations did not approve, and release from quarantine, all components, packaging, and labels before they were used in your dietary supplement products. Further, under 21 CFR 111.140(b)(2), you must make and keep records for fulfilling the requirements of subpart F, including written documentation that quality control personnel performed the review, approval, or rejection requirements. Subpart F includes the requirement in 21 CFR 111.120(e) that you have quality control operations for approving, and releasing from quarantine, all components, packaging, and labels before they are used.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. Your response states that you have designated one person to act as quality control and to perform all quality control functions but failed to provide information or documentation to demonstrate that your quality control personnel performed the review, approval, or rejection related to approving components, packaging, and labels and releasing them from quarantine.
6. You failed to include documentation, at the time of performance, in a batch production record, that quality control personnel approved and released, or rejected, the batch for distribution, including any reprocessed batch, to comply with 21 CFR 111.260(1)(3) and 21 CFR 111.123(a)(8). Specifically, our review of your document entitled “Work Order” indicates that you manufactured the following dietary supplements, but you did not have a quality control person document the approval and release, or rejection, of the lots for distribution prior to release of the product for distribution.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. Your response states that you have designated one person to act as quality control personnel to perform these quality control functions but failed to provide documentation to demonstrate that your quality control personnel has performed the review, approval, or rejection of your finished dietary supplements.
7. You failed to make and keep records of your written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment that are used to manufacture, package, label, or hold components or dietary supplements, as required by 21 CFR 111.35(b)(1)(ii). Specifically, you did not have written procedures for calibrating, inspecting, and checking your digital weighing scale or mechanical blender.
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. You stated that you have contacted the (b)(6) but you have not provided evidence of a written procedure to comply with this requirement nor have you provided any timeframe for correction of this violation.
8. You failed to package and label in a way that ensures that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.415. Specifically, your firm packages and labels the Super MSM, Super N, Super Inositol, and White Crystalline Powder Caffeine Dietary Supplement products but you do not have master manufacturing records to control and ensure that you are using the correct packaging and labeling to package and label these products. At a minimum, you should have access to master manufacturing records for these products that contain the information set forth in 21 CFR 111.210(g), 21 CFR 111.210(h)(1), and 21 CFR 111.210(h)(3).
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. You state that you have discontinued your manufacturing of the Super B product; however, you must have master manufacturing records for all other dietary supplement products that you pack, label, hold and distribute.
9. You failed to establish a batch production record in accordance with the requirements in 21 CFR 111.255 and 111.260. You must prepare a batch production record every time you manufacture a batch of a dietary supplement [21 CFR 111.255(a)]. However, you did not prepare a batch production record for all of the finished dietary supplements manufactured at your facility.
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, as required by 21 CFR 111.260(c).
e. Documentation, at the time of performance, that quality control personnel reviewed the BPR, and approved and released, or rejected, the packaged and labeled dietary supplement, including any repackaged or relabeled dietary supplement [21 CFR 111.260(l)(1) and (4).
10. You failed to make and keep documentation of training, including the date of the training, the type of the training, and the person(s) trained, as required by 21 CFR 111.14(b)(2).
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. Your response did not indicate how you will meet this requirement going forward.
11. 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 the review and investigation of product complaints. In addition, you failed to make and keep the records of these procedures, as required by 21 CFR 111.570(b)(1).
We have reviewed your August 13, 2012 dated response and determined it to be inadequate. You indicated that you are “working on” written procedures. However, you did not provide a copy of what has been written or an estimated time of completion.
12. You failed to establish and follow written procedures to fulfill the requirementsrelated to returned dietary supplements, as required by 21 CFR 111.503. Specifically, you have not established written procedures that specify the procedures to be followed when a dietary supplement is returned by a customer. In addition, your firm failed to make and keep records of these procedures, as required by 21 CFR 111.535(b)(1).
Your August 13, 2012 dated response was reviewed and determined inadequate. You indicated that your firm does not take product returns; however, you are still required to establish and follow a written procedure in the event you receive returned dietary supplements.
Your responses to Observations #11 and 13 in the FDA-483, not discussed here, are considered adequate. We will verify these corrections during our next routine inspection.
Your Super N, Super Inositol, and Caffeine Dietary Supplement 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 fail to bear nutrition labeling (“Supplement Facts” panel) as required by 21 CFR 101.36.
Further, Super MSM and Super N Dietary Supplements are misbranded within the meaning of sections 403(i)(1) and 403(s)(2)(B) of the Act in that the labels fail to identify the products using the term dietary supplement in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term "dietary supplement" as part of the product's statement of identity, except that the word "dietary" may be deleted and replaced by the name of the dietary ingredient in the product.
Your Super N, Super Inositol, and White Crystalline Powder Caffeine Dietary Supplement products are misbranded under section 403(y) of the Act in that the labels fail to include a domestic address or domestic phone number through which the responsible person (as described in section 761(b)) may receive a report of a serious adverse event with such dietary supplement.
In addition, your Super MSM product is promoted for a condition that causes the product to be a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)]. The claim on your labeling makes this a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your products with these claims violates the Act. You can find the Act and implementing regulations on FDA's website at http://www.fda.gov.
Your product is not generally recognized as safe and effective for the above referenced use and, therefore, it 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 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. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not intended to be an all-inclusive list of violations at your facility or in your products. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action may result in regulatory action being initiated by FDA without further notice. For example, we may take further action to seize your products and/or enjoin your firm from operating.
In addition, we note that the labels for the products Super N and Super Inositol bear claims that appear to be claims described under section 403(r)(6) of the Act [21 U.S.C. § 343(r)(6)] but do not include the mandatory disclaimer required by section 403(r)(6) of the Act and 21 CFR 101.93(b)-(e).
We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions or steps towards long term, corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining 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 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)]. 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.
If you have questions regarding any issues in this letter, please contact Dr. Raymond W. Brullo, Compliance Officer at 949-608-2918 or raymond.brullo@fda.hhs.gov.

References: § 342
 § 343
 § 321
 § 321
 § 301
 § 331
 § 343
 § 379
 § 379