U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. World Organic Corp. - 492776 - 06/17/2016
  1. Warning Letters

WARNING LETTER

World Organic Corp. MARCS-CMS 492776 —


Recipient:
World Organic Corp.


United States

Issuing Office:
Los Angeles District Office

United States


  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone:    949-608-2900
FAX:    949-608-4415

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
June 17, 2016 
 
WL # 32-16
 
Mr. Paul J. Licata, President
World Organics Corp.
5242 Bolsa Avenue, Suite 3
Huntington Beach, CA 92649
 
Dear Mr. Licata:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, World Organics Corp., located at 5242 Bolsa Avenue, Suite 3 Huntington Beach, California on February 2–3, and 8, 2016. The inspection revealed serious violations of the 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 the 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 requirements for dietary supplements. 
 
Additionally, during the inspection our investigator collected labels for your products. Based on our review of these labels, your “Nature’s Concept” and (b)(4) products are misbranded under section 403 of the Act [21 U.S.C. § 343]. 
 
We have received your written response dated February 29, 2016 concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on February 8, 2016. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
 
The significant violations documented during the inspection include, but are not limited to, the following:
 
Dietary Supplement CGMP Violations
 
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.
 
1.    You failed to establish the required specifications for points, steps, or stages 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. Specifically,
  • You failed to establish specifications for dietary supplement labels and for packaging that may come in contact with the dietary supplements, as required by 21 CFR 111.70(d). Specifically, your firm has not established specifications for all finished product labels and packaging components such as white bottles, amber bottles, caps and cotton as observed during the review of (b)(4) lot number (b)(4) which was packaged as 50 count tablets into 100cc/(b)(4) bottles with cotton and a white cap on 02/03/2016.
We note that you acknowledged during the inspection that you rely on the supplier’s certificate of analysis related to testing results for component specifications for identity, purity, and strength for sodium copper chlorophyllin used in the manufacture of the following dietary supplements: “Liquid Chlorophyll 50 mg,” “Liquid Chlorophyll 100 mg,” “Chlorophyll 60 mg Capsules” and “Mega Chlorophyll 100 mg capsules.” We also note that you acknowledged during the inspection that your firm has not established complete specifications for the products that you formulate, or understand what specifications your contract manufacturer(s) has established for identity, purity, strength, composition and limits on contaminants for your finished dietary supplements that your contract manufacturer(s) manufactures on your behalf, which you distribute under your own label. In your response dated February 29, 2016, you stated that you have reviewed your products and updated the “Product Protocol” and Receiving Sheets” with specifications.
 
Further, we note that, based on your protocols, your firm did not establish specifications for the (b)(4) “Vitamin A 10,000I.U. Fish Liver Oil Softgel,” “Chlorophyll 60 mg capsule,” “Mega Chlorophyll 100mg capsule,” (b)(4) “Liquid Chlorophyll 50 mg, Natural Mint Flavor, 16 oz.” and “Liquid Chlorophyll 100 mg, 16 oz.” products as evidenced by the following:
 
i.  Product (b)(4) protocol does not include purity, complete composition, limits on contaminants such as microbial and heavy metal.
ii.  Product (b)(4), “Vitamin A 10,000I.U. Fish Liver Oil Softgel” protocol does not include identity, purity, composition and limits on contaminants for heavy metals.
iii.  Product (b)(4), “Chlorophyll 60 mg capsule” protocol does not include purity, strength, composition and limits on contaminants such as microbial and heavy metal.
iv.  Product (b)(4) Mega Chlorophyll 100mg capsule” protocol does not include purity, strength, composition and limits on contaminants such as microbial and heavy metal.
v.  Product (b)(4) protocol does not include purity, strength, composition and limits on contaminants such as microbial and heavy metal.
vi.  Product “Liquid Chlorophyll 50 mg, Natural Mint Flavor, 16 oz.” does not have product specifications for identity, purity, strength, composition and limits on contaminants such as microbial.
vii.  Product “Liquid Chlorophyll 100 mg, 16 oz.” does not have product specifications for identity, purity, strength, composition and limits on contaminants such as microbial.
 
To the extent you receive products from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier), you must establish specifications to provide sufficient assurance that the product you receive is adequately identified and is consistent with your purchase order, as required by 21 CFR 111.70(f).
 
To the extent that another firm manufactures dietary supplements on your behalf as a contract manufacturer (such as (b)(4)), that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act). 
 
In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105).
 
2.    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, as required by 21 CFR 111.103.
 
Specifically, you acknowledged during the inspection that your firm has no written procedures established or documented for material review and disposition (i.e. components, packaging, labels, returned products), release of finished product, packaging operations, labeling operations, supplier qualification, calibration and maintenance of equipment.
 
We acknowledge your response dated February 29, 2016.You state that you are still working on revising your “Manual of Operations;” Your response further states that employees have been trained and are now maintaining cleaning logs and will start maintaining the sanitation and maintenance records for the packaging machine. We also acknowledge the “Packaging and Room Cleaning” and “Machine Servicing” forms you provided for your (b)(4) packaging machine. We intend to verify the adequacy of this corrective action and other corrective actions at a future inspection.
 
3.    You failed to establish and follow written procedures for returned dietary supplements as required by 21 CFR 111.503. Specifically, you have not established written procedures for the disposition of returned dietary supplements.
 
We acknowledge your response dated February 29, 2016. You state that you are still working on revising your “Manual of Operations. We intend to verify the adequacy of this corrective action.
 
Misbranded Dietary Supplements
 
Our review of your product labels revealed that your products are misbranded within the meaning of section 403 [21 U.S.C. § 343] of the Act and the regulations implementing the food labeling requirements of the Act, which are found in 21 CFR Part 101, as discussed further below. 
 
1.    Your (b)(4) and “Vitamin A 10,000 I.U. Fish Liver Oil” products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the products are fabricated from two or more ingredients, and each ingredient is not declared on the labels by the common or usual name, in accordance with 21 CFR 101.4. For example,
  • According to your supplier label for your (b)(4) your products are manufactured using “rice bran, cellulose, stearic acid, silicon dioxide, guar gum and ethylcellulose.” However, you fail to list these ingredients on your finished product labels. Moreover, your product labels declare lecithin as an “other ingredient;” however, this ingredient is not declared on your supplier label.
  • Your “Vitamin A 10,000 I.U. Fish Liver Oil” product label declares soybean oil in the other ingredient statement; however, this ingredient is not on the supplier’s label. Moreover, the supplier label declares mixed natural tocopherols and purified water; however, these are not declared on the finished product label.
2.    Your (b)(4), and “Mega Chlorophyll 100 mg” products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving sizes declared on the labels are 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. For example:
  • The (b)(4) directions of use suggest the consumer take one (1) tablet (3) times daily, preferably with a meal, but the serving size lists 3 tablets. The serving size listed should be 1 tablet.
  • The “Chlorophyll 60 mg,” and “Mega Chlorophyll 100 mg” directions of use suggest the consumer take one (1) or two (2) capsules daily; however, the serving size lists1 capsule. The serving size listed should be 2 capsules.
3.    Your “Nature’s Concept Vitamin A 10,000IU Fish Liver Oil” and (b)(4) 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 presentation of the nutrition information on the labeling of your product does not comply with 21 CFR 101.36. For example,
 
Your (b)(4) product labels list several ingredients, including alfalfa, parsley, and watercress outside the nutrition label of the supplement facts panel. These dietary ingredients should be listed inside the supplement facts panel along with their quantitative amount by weight per serving in metric units in accordance with 21 CFR 101.36(b)(3).
  • By comparison, the supplier label for the “Nature’s Concept Vitamin A 10,000IU Fish Liver Oil” indicates total calories, calories from fat, total fat and cholesterol are present in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with 101.9(c), yet these (b)(2)-dietary ingredients are not declared on the product label. 
4.    Your “Mega Chlorophyll 100 mg” product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the label fails to include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).
 
5.    Your “Nature’s Concept Vitamin A 10,000IU Fish Liver Oil” product is misbranded within the meaning of section 403(w) of the Act [21 U.S.C. § 343(w)] because the label fails to identify the species of fish that is the source of the fish ingredient which is a major food allergen.
  
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, such as seizure and/or injunction.
 
In addition to the above violations, we offer the following comments:
  • Your “Shark Cartilage” product is not an oil and is characterized as a fishery product. You do not have a HACCP plan to control the hazard of undeclared allergens and do not maintain sanitation control records. Please provide documentation for all your fish derived products regarding the product’s purity and specifications.
In accordance with 21 CFR 123.6(g), as a processor of fishery products you must have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123.  http://www.fda.gov/downloads/food/guidanceregulation/ucm251970.pdf
  • We acknowledge that you have revised your “Packaging and Repackaging Check List” provided with your response to address the missing elements required by 21 CFR 111.255(b) and 111.260. However, it is not clear whether these additional columns will capture all the required information (i.e. sanitation time, label(s) included). In addition, although you have added a section for quality control review, we are not able to determine whether this is being conducted. In order to assist the agency in evaluating the adequacy of your corrective action, please provide a sample of a complete batch record for review with your response. 
  • Your (b)(4)  “Chlorophyll 60 mg,” “Mega Chlorophyll 100 mg,” “Liquid Chlorophyll 50 mg,” “Liquid Chlorophyll 100 mg,” (b)(4) and “Nature’s Concept Vitamin A 10,000IU Fish Liver Oil” product labels bear the statement “Daily Values are based on a 2,000 calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D). None of those dietary ingredients is present in amounts allowed to be declared on the label, so the statement is not permitted.
  • Your (b)(4) does not bear the footnote text, “Daily Value not established,” for the dietary ingredients that bear the footnote symbol on the Supplement Facts label. 
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. 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, the FDA may assess fees to cover any reinspection-related costs.
 
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.
 
Your response should be sent to:
 
CAPT Larry Howell
Acting Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
19701 Fairchild
Irvine, CA 92612
 
If you have any questions about the content of this letter, please contact Marco Esteves, at 949-608-4439.
 
 
Sincerely,
/S/ 
CDR Steven E. Porter, Jr.
Los Angeles District Director
 
 
Cc: 
David M. Mazzara, Ph.D.
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435