Inspections, Compliance, Enforcement, and Criminal Investigations
Caribe Natural LLC 5/14/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
RETURN RECEIPT REQUESTED
May 14, 2012
Maida E. Chaveco
Caribe Natural, LLC
13121 SW 122nd Avenue
Miami, FL 33186-6231
Dear Mrs. Chaveco:
This is to advise you that the U.S. Food and Drug Administration (FDA) inspected your firm Caribe Natural, LLC from September 6, 2011 to November 23, 2011, located at 13121 SW 122nd Ave, Miami, Florida.
During the inspection, you informed our investigators that your firm is an own-label distributor of your GERMA® brand dietary supplements that has entered into agreements with contract manufacturers to manufacture your dietary supplement products. The Vice-President of your firm, Mr. Gerardo Barillas, stated that you purchase a competitor’s product and request contract manufacturers to manufacture the same product so that you can distribute the product under your own label. Mr. Barillas stated that you use the same list of ingredients that is printed on the competitor’s brand label for the label on your product. As an own-label distributor that contracts with other manufacturers to manufacture dietary supplements that your firm releases for distribution under your firm’s name, FDA considers you to be a manufacturer of such dietary supplements. You have ultimate responsibility for the dietary supplements that you introduce or deliver for introduction into interstate commerce.
The inspection revealed serious violations of the Current Good Manufacturing Practice (CGMP) regulation 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 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 the dietary supplement products have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements.
In addition, after reviewing your products’ labels and your website www.caribenatural.com, FDA has determined that your “Colostrum ‘A’ Plus” and “Urobiol” products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product labels and website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease in humans. The marketing of your products with these claims violates the Act.
You may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
Dietary Supplement CGMP Violations
1. Your firm failed to make and keep written procedures for the responsibility of quality control operations, as required by 21 CFR 111.103 and 21 CFR 111.140(b)(1). As an own-label dietary supplement distributor that contracts with a manufacturer to manufacture a dietary supplement that you distribute under your own label, you have an obligation to know what and how manufacturing activities are performed so that your firm can make decisions related to whether your packaged and labeled dietary supplement products conform to established specifications and whether to approve and release the products for distribution [See 72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Your firm's quality control personnel must ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of your dietary supplements and that your dietary supplements are packaged and labeled in accordance with established specifications, as required by 21 CFR 111.105 and 21 CFR 111.120(b).
We have reviewed your response dated December 12, 2011 and determined it to be inadequate. Your procedures related to quality control did not address important requirements for quality control operations. Specifically, your procedures did not address your quality control operations' responsibilities for conducting a material review and making a disposition decision for returned products, as required by 21 CFR 111.103 and 21 CFR 111.113(a)(5), or for approving for release or rejecting any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
2. Your firm failed to make and keep written procedures for product complaints, as required by 21 CFR 111.570(b)(1). Specifically, your firm did not have written procedures for the handling of product complaints regarding the dietary supplement products you distribute and for adequately investigating complaints and documenting the findings of an investigation and follow-up.
We have reviewed your response dated December 12, 2011 and determined it to be inadequate. Specifically, it appears you have provided a written form for documenting product complaints and the action taken in response. However, you have not provided written procedures on how to investigate the complaint and how quality control personnel will be involved in the review and approval process.
3. Your firm failed to hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected, as required by 21 CFR 111.455(a), and your firm failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you informed our investigators that you do not measure the temperature or humidity levels in your product storage warehouse.
We have reviewed your response dated December 12, 2011 and determined it to be inadequate. While your response provides a form for documenting the person responsible for temperature and humidity record-keeping, your response did not establish written procedures for controlling and monitoring the temperature, humidity, and light of your facility where finished and bulk products are stored.
4. Your firm failed to make and keep written procedures for returned dietary supplements, as required by 21 CFR 111.535(b)(1). Specifically, 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 response dated December 12, 2011 and determined it to be inadequate. Your response indicates that you will discard damaged and/or expired products. However, your procedures failed to include procedures for identifying and quarantining returned dietary supplements until quality control personnel conduct a material review and make a disposition decision, as required by 21 CFR 111.510. Your written procedures also did not include procedures for when a returned dietary supplement may be salvaged in accordance with 21 CFR 111.520. In addition, as required by 21 CFR 111.503 and 21 CFR 111.535(b), you failed to establish written procedures for making and keeping the following records: any material review and disposition decision on a returned dietary supplement; the results of any testing or examination conducted to determine compliance with product specifications established under 21 CFR 111.70(e); documentation of the reevaluation by quality control personnel of any dietary supplement that is reprocessed; and the determination by quality control personnel of whether the reprocessed dietary supplement meets product specifications established in accordance with 21 CFR 111.70(e).
5. Your firm did not establish written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, you indicated to our investigator that you receive bulk dietary supplement product from your contract manufacturer, but you have no written procedures for holding and distributing operations.
We have reviewed your response dated December 12, 2011 and determined it to be inadequate. Your “Warehouse Product Receiver Guidelines” state that “[t]he goods must be reviewed and checked properly before being placed on the shelves.” However, your procedures did not address holding dietary supplements under conditions that do not lead to the mix-up, contamination, or deterioration of dietary supplements, as required by 21 CFR 455(c).
Further, our review of the inspectional evidence, including the information you provided to our investigators, revealed the following violations:
6. Your firm failed to establish a specification for any 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 master manufacturing record, as required by 21 CFR 111.70(a).
7. Your firm failed to establish specifications for each component that you use in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b).
8. Your firm failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR 111.205(a).
Unapproved New Drugs
Examples of some of the therapeutic claims observed on your product labels and website include:
COLOSTRUM “A” PLUS DIETARY SUPPLEMENT– 500 mg (120 CAPS)
- “Helps to combat Virus and Bacteria”
- “IgG mother’s immune factor neutralizes and destroys poison toxins and invading pathogens”
UROBIOL With Nirurin
- “[D]isperses calcification. Breaks kidney gallstones.”
Because your “Colostrum ‘A’ Plus” and “Urobiol” products are not generally recognized as safe and effective for the above referenced uses, they are “new drugs” as defined in section 201(p) of the Act [21 U.S.C. § 321(p)]. Under section 505(a) of the Act [21 U.S.C. § 355(a)], new drugs may not be legally marketed in the U.S. without prior approval from FDA. FDA approves new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Further, because your “Colostrum ‘A’ Plus” and “Urobiol” products are 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 layperson can use these drugs safely for their intended purposes. Thus, your products are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that their labeling fails to bear adequate directions for their intended uses. 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)].
Misbranded Dietary Supplements
Your GERMA 9 Syrups, Vigaril Natural Stimulant, and Germa Colostrum “A” Plus 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 failed to comply with 21 CFR 101.36 as follows:
- Under 21 CFR 101.36(c)(1), dietary ingredients contained in the proprietary blend that are listed under paragraph (b)(2) of this section must be declared in accordance with paragraph (b)(2) of this section. Specifically, your Vigaril Natural Dietary Supplement and Germa 9 Syrup products list Zinc Gluconate, Niacinamide, and Vitamin C, respectively, which are dietary ingredients under paragraph (b)(2). However, they are not declared in the proprietary blend in accordance with 21 CFR 101.36(c)(1) because the dietary ingredients which have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in 21 CFR 101.9(c) are not listed separately from the other dietary ingredients in your proprietary blend which do not have an RDI or DRV established. In addition, dietary ingredients in the Germa 7 and 9 Syrup products must be indented under the “Proprietary Herbal Blend, as required by 21 CFR 101.36(c)(2).
- Under 21 CFR 101.36(b)(2) and (3), the names of dietary ingredients that have daily values must be listed in a specified order and in a column display and dietary ingredient that do not have daily values must be listed in a column or linear display. Specifically, your Germa Colostrum “A” Plus Dietary Supplement product does not lists the individual dietary ingredients that you described as “vitamins” and “minerals” in the nutrition information as dietary ingredients that have an RDI or DRV established, as required by 21 CFR 101.36(b)(2).
- Under 21 CFR 101.36(b)(2)(iii), the percent of the daily value must be declared for all dietary ingredients for which FDA has established daily values. Specifically, your Germa Malt Extract with Vitamins Reinforced by B-12 dietary supplement does not list the daily values for the dietary ingredients in your product.
Your Vigaril Natural Stimulant dietary supplement product is misbranded within the meaning of section 403(u) of the Act [21 U.S.C. § 343(u)] in that it purports to contain ginseng, but the purported ginseng ingredient is not from a plant classified with the genus Panax. Section 403(u) of the Act, added by the Farm Security and Rural Investment Act of 2002 (Pub. L. 107-171), provides that the term "ginseng" may only be considered to be a common or usual name (or part thereof) for any herb or herbal ingredient derived from a plant classified within the genus Panax. Your product contains an ingredient identified as Siberian Ginseng (Eleutherococcus senticosus). That ingredient may not be declared under a name that includes the term "ginseng" because it is not from the genus Panax.
Your Vigaril Natural Stimulant, Germa 9 Syrup, Germa 7 Syrups, Germa Colostrum “A” Plus, Germa Malt Extract with Vitamins Reinforced by B-12 and Germa Urobiol with Nirurin dietary supplement products are misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the labels fail to bear a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event associated with such dietary supplement.
Your Vigaril Natural Stimulant and Germa Urobiol with Nirurin dietary supplement products are misbranded within the meaning of section 403(s)(2)(C) of the Act [21 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).
Your Vigaril Natural Stimulant, Germa Malt Extract with Vitamins Reinforced by B-12 and Germa Urobiol with Nirurin 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. As required by 21 CFR 101.15(c), if a product label contains any representation in a foreign language or foreign characters, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. For example, you do not repeat the nutrition labeling information ("Supplement Facts panel) information in Spanish.
Your Germa Colostrum “A” Plus Dietary Supplement is misbranded within the meaning of section 403(i)(2) in that it is fabricated from two or more ingredients, but the label fails to list the individual excipients as required by 21 CFR 101.4(g). Your label lists “excipients,” but fails to list the names of the individual excipients.
The violations mentioned above are not intended to be an all-inclusive list of violations that exist in connection with your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
You should take prompt action to correct the violations described above and prevent their further recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct the violations noted above. 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.
Please send your reply to the Food and Drug Administration, Attention: Winston R. Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
Emma R. Singleton
Director, Florida District