The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Ibitta Enterprises, Inc., located at 4593 Firestone Blvd, South Gate, CA 90280-3343 on May 10, May 14, May 16, and May 21, 2019. Based on the Inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on the FDA's home page at http://www.fda.gov.
Adulterated Dietary Supplements
The inspection of your facility revealed serious violations of FDA' s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), 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 CGMP regulations for dietary supplements.
The significant violations documented during the inspection include, but are not limited to, the following:
1. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength and composition of the finished batch of 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). Specifically, you have not established such specifications for the dietary supplements you manufacture.
Once you have established the required finished product specifications, you must verify that the specifications are met in accordance with 21 CFR 111.75(c), and you must make and keep records of such specifications and the verification thereof in accordance with 21 CFR 111.95.
We have received your response, dated June 10, 2019, in which you state that you are currently working with a third-party lab partner to help you establish the required specifications. We cannot evaluate the adequacy of your corrective action because you have not provided such finished product specifications or evidence that you have begun implementing such specifications.
2. You failed to establish specifications for each component that you use in the manufacture of a dietary supplement, including identity specifications and specifications necessary to ensure the purity, strength, and composition of dietary supplements manufactured using the components, as required by 21 CFR 111.70(b)(1) and (b)(2). Specifically, you failed to establish identity specifications for most of the components you use in your dietary supplements, and you have not established any written specifications to ensure the purity, strength, and composition of your dietary supplements manufactured using the components.
We have received your response, dated June 10, 2019, in which you state that you are currently working to identify proper testing methods for identity of dietary ingredients in order to establish identity specifications, and that you are in the process of developing such specifications. We cannot evaluate the adequacy of your corrective action because you have not provided such finished product specifications or evidence that you have begun implementing such specifications.
3. You failed to establish specifications for the dietary supplement labels (label specifications), as required by 21 CFR 111.70(d). Specifically, you have no written label specifications for your finished dietary supplement products.
We have received your response, dated June 10, 2019, in which you state that you have drafted and implemented a new written SOP for material and product specifications which include product labels, and ·that you planned to establish label specifications for all labels used. We cannot evaluate the adequacy of your corrective action because you did not provide such labeling specifications or evidence that you have begun implementing such specifications.
4. You failed to prepare and follow a written master manufacturing record (MMR) that identifies specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement, as required by 21 CFR 111.205(b)(1) and 21 CFR 111.210. Specifically, your MMR fails to include required information such as (but not limited to) written instructions for the following:
- Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];
- Written instructions for manual operations which include one person weighing or measuring a component and another person verifying the weight or measure, and one person adding each component and another person verifying the addition [21 CFR 111.210(h)(3)(ii)];
- Corrective action plan to use when a specification is not met [21 CFR 111.210(h)(5).
We have received your response, dated June 10, 2019, in which you state that you have drafted and implemented a new written SOP to specify requirements for MMRs and that you planned to establish revised MMRs for all dietary supplement products. We also
acknowledge the revised MMR procedure for Piñalinaza included in your response. Your new MMR for Piñalinaza is insufficient to satisfy the requirements for complete MMRs because it is deficient in the requirements specified above. We cannot evaluate the adequacy of your corrective actions with respect to other products because we have not seen the remaining MMRs you plan to implement.
5. Your batch production record (BPR) failed to include complete information relating to the production and control for each batch, as required by 21 CFR 111.255(b) and 21 CFR 111.260. Specifically, your BPRs reviewed during the inspection do not include required elements including (but not limited to):
- The identity of equipment used in producing the batch such as scales, blender and filler [21 CFR 111.260(b)];
- The date and time of maintenance, cleaning, and sanitizing of the equipment used in producing the batch or a cross-reference to the records [21 CFR 111.260(c)];
- The unique identifier that you assigned to each packaging and label used [21 CFR 111.260(d)];
- 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, such as the weight of finished product [21 CFR 111.260(g)];
- Documentation, at the time of performance, of the manufacture of the batch, of the date on which each step of the MMR was performed, 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 each batch, and the initials of the person responsible for verifying the addition of components to each batch [21 CFR 111.260(j)];
- Documentation, at the time of performance, of packaging and labeling operations, including the unique identifier that was assigned to packaging and labels used, and any label reconciliation [21 CFR 111.260(k)(1)] and an actual or representative label used in the batch or a cross-reference to the physical location of the actual or representative label [21 CFR 111.260(k)(2)].
We have received your response, dated June 10, 2019, in which you state that you have drafted a new written SOP to specify requirements for BPRs and that you were planning to implement updated BPRs. We cannot evaluate the adequacy of your corrective action because you have not provided such revised BPRs or evidence that you have begun implementing them.
Misbranded Dietary Supplements
In addition, your Lal-K-Chofa, Leche de Alpiste Canary Seed Dietary Supplement, Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g), and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement products are misbranded dietary supplements under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows:
1. Your Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g) and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically:
- Your Pinalinaza Flaxseed, Cactus, and Fruit Powder Mix Dietary Supplement Pineapple (470g) label lists the ingredient "Stevia (leaf) Extract" but does not specify the steviol glycoside.
- Your Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g), and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement labels declare omega 3 fatty acids and omega 6 fatty acids but fail to name the specific fatty acids.
2. Your Lal-K-Chofa, Leche de Alpiste Canary Seed Dietary Supplement, Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g), and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement products are misbranded within the meaning of section 403(f) of the Act [21 U.S.C. §343(f)] because the product labels contain information in two languages, but do not repeat all the required information in both languages. For example, the statement of identity, Supplement Facts, and ingredients information must be declared in both languages as required by 21 CFR 101.15(c)(2).
3. Your Lal-K-Chofa product is misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR 101.12(b) Table 2. Furthermore, the serving size must be expressed in a common household measure such as tablespoon [21 CFR 101.9(b)(5)(i)]. The product's suggested usage states "mix 2 tablespoons (14 g)," but the serving size lists "½ once (14 g)." The serving size listed should be "2 tablespoons (14 g)" with the option of also declaring ounce following the metric measure separated by a slash ("2 tablespoons (14 g / ½ ounce)").
4. Your Lal-K-Chofa, Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g), and Nopalinaza Plus Faxseed and Cactus Powder Mix Dietary Supplement products are misbranded within the meaning of sections 403(s)(2)(A) and 403(q)(5)(F) of the Act [21 U.S.C. §§343(s)(2)(A) and 343(q)(5)(F)] in that the labels fail to list the name of each dietary ingredient of the supplements that are described in section 201(ft) and the quantity of each such dietary ingredient, as required by 21 CFR 101.36. For example:
- Your Lal-K-Chofa label suggests that the product contains Milk Thistle Powder, Senna (leaf) Powder, and Artichoke Powder. However, these dietary ingredients and their quantitative amounts by weight per serving are not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).
- Your Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple label suggests that the product contains Senna (leaf) Powder. However, this dietary ingredient and its quantitative amount by weight per serving is not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).
- Your Nopalinaza Plus Faxseed and Cactus Powder Mix Dietary Supplement label suggests that the product contains Senna Leaf Powder. However, this dietary ingredient and its quantitative amount by weight per serving is not listed in the Supplement Facts label in accordance with 21 CFR 101.36(b)(3).
In addition, your Lal-K-Chofa, Leche de Alpiste Canary Seed Dietary Supplement, Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g), and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement products are further misbranded within the meaning of section 403(q)(5)(F) of the Act (21 U.S.C. § 343 (q)(5)(F)) in that the products do not present nutrition information on the labeling as required by 21 CFR 101.36 and 21 CFR 101.9. For example:
- Your Leche de Al piste Canary Seed Dietary Supplement, Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g), and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement labels list (b)(2)-dietary ingredients in amounts that are zero or that can be declared as zero. Any (b)(2)-dietary ingredients not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).
- Your Lal-K-Chofa label declares saturated fat but does not provide a quantitative weight or percent Daily Value (DV) as required by 21 CFR 101.36(b)(2). However, if saturated fat is not present or in an amount that can be declared as zero in 101.9(c), it shall not be declared in accordance with 21 CFR 101.36(b)(2)(i).
- Your Leche de Alpiste Canary Seed Dietary Supplement label fails to list the dietary ingredients in the correct order as required by 21 CFR 101.36(b)(2)(i)(B). Furthermore, the label presents a light bar within the list of (b)(2)-dietary ingredients whereas the (b)(2)-dietary ingredients must only be separated by hairline rules.
- Your Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g) and Nopalinaza Plus Flaxseed and Cactus Powder Mix Dietary Supplement labels declare soluble fiber and insoluble fiber but fail to indent these dietary ingredients under dietary fiber as required by 21 CFR 101.9(c)(6)(i) and 101.36(b)(2)(i)(B).
- Your Pinalinaza Flaxseed, Cactus and Fruit Powder Mix Dietary Supplement Pineapple (470g and 150g) labels declare the dietary ingredient bromelain but fail to express the amount using a metric measure as required by 21 CFR 101.36(b)(3)(ii)(A).
5. Your Lal-K-Chofa product is misbranded within the meaning of section 403(s)(2)(C) of the Act [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). Specifically, your Lal-K-Chofa product label fails to include the part of the plant from which milk thistle powder and artichoke powder are derived.
This letter is not intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter. Failure to promptly correct these violations may result in enforcement action without further notice, including, without limitation, seizure and/or injunction.
We also offer the following comments:
1. Your Pinalinaza Flaxseed, Cactus, and Fruit Powder Mix Dietary Supplement Pineapple (470g) product label lists grapefruit powder as an ingredient, but it is not clear from the batch record obtained during the FDA inspection ending May 21, 2019, if grapefruit powder is an ingredient.
2. We note the label for your Lal-K-Chofa product identifies a weight of 312 g, but your firm's Operational Manager informed our investigator the actual product contains 500 g of product. The net quantity of contents declaration is required to be accurate in accordance with 21 CFR 101.7.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover the FDA's costs for certain activities, including reinspection-related costs. Are 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. 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, the FDA may assess fees to cover any reinspection-related costs.
