Inspections, Compliance, Enforcement, and Criminal Investigations
Creation's Garden Natural Products, Inc. 8/28/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
August 28, 2012
Mr. Dino R. Guglielmelli, President and CEO
Creation’s Garden Natural Products, Inc.
24849 Anza Drive
Valencia, CA 91355
Dear Mr. Guglielmelli:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing, packaging, and labeling facilities, located at 24849 Anza Avenue, 24887 Avenue Rockefeller, 24749 Avenue Rockefeller, and 27615 Avenue Hopkins in Valencia, California, and 28926 Hancock Parkway in Castaic, California, from January 30 through March 6, 2012. During the inspection, our investigators identified a number of significant violations of the Current Good Manufacturing Practice (CGMP) regulations for Dietary Supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
These CGMP 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 supplements have been prepared, packed, or held under conditions that do not meet CGMP regulations for dietary supplements. Our investigators’ observations were presented to you on form FDA-483, Inspectional Observations, at the conclusion of our inspection on March 6, 2012.
In addition, our investigators collected labels and samples of your products during the inspection of your facilities. Based on our review of these labels and samples, your (b)(4) pediatric electrolyte solution and LunaSX Women’s Intimate products are misbranded under section 403(a) of the Act [21 U.S.C. § 343(a)]. Further, our review of your website, http://www.creationsgarden.com, revealed that you promote your productsBowel & Parasite Cleanse and Parasite Cleanse in violation of section 505(a) of the Act [21 U.S.C. § 355(a)].
The FDA also determined that your firm manufactures LUNA SX Water Base Lubricant. Under section 201(h) of the Act, 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
You may find the Act and FDA regulations through links at FDA’s home page at http://www.fda.gov.
Dietary Supplement CGMP Violations
The inspection revealed the following violations:
- Your firm failed to verify that your finished batches of dietary supplements meet product specifications for identity, purity, strength, and composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch, as required by 21 CFR 111.75(c). You may verify that these specifications are met by testing or examining (1) every finished batch or (2) a subset of finished batches for each of the dietary supplements you manufacture [21 CFR 111.75(c)]. If you test a subset of finished batches, you must identify the subset using a sound statistical plan [21 CFR 111.75(c)].
However, your batch production records for the following released finished dietary supplement products lacked finished product testing to verify that they met finished product specifications for identity, purity, strength, and composition:
- LunaSX Male Performance (lot 9394): label claim of 400 mg proprietary blend
- (b)(4): label claims for zinc, selenium, Korean ginseng, saw palmetto, and beta sistosterols
We have reviewed your response to the FDA-483 dated March 27, 2012. Your response does not provide the information necessary for FDA to verify that you are conducting finished product testing for the dietary supplements that you manufacture in accordance with 21 CFR 111.75(c). We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
- Your firm failed to qualify the suppliers of components other than dietary ingredients 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 confirm the identity of a component that is not a dietary ingredient and 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 relied on the certificates of analysis from the suppliers of the components (b)(4) ginseng root powder (b)(4), used in the manufacturing of your dietary supplement product (b)(4), and (b)(4) ginseng root powder (b)(4), used in the manufacturing of your dietary supplement product LunaSX Male Performance. 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.
We have reviewed your response to the FDA-483 dated March 27, 2012. You stated that you have “instituted a testing policy against incoming component specifications.” You also attached a revised SOP that states that “[a]ll information contained on . . . the Supplier’s [c]ertificates of [a]nalysis will be subject to verification testing to insure compliance with cGMP requirements.” However, your response is inadequate because you failed to provide any supporting documentation that you have qualified your suppliers in order to use their certificates of analysis. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility. We also recommend that you specifically reference the requirements of 21 CFR 111.75(A)(2)(ii)(A) and (C) in your SOP.
- Your firm did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements, including performing manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination, as required by 21 CFR 111.365(a). Specifically, during the pre-weighing of components for the manufacturing of the product (b)(4) Whey Vanilla Protein (b)(4) at your Anza Avenue manufacturing facility on 1/31/12, our investigator observed one of your employees use the same metal scoop for measuring and dispensing the component Vanilla (b) (4) and the component Alpha ketoglutarate acid (b)(4) without being cleaned and sanitized between uses. Our investigator observed the same employee touch one raw material with his gloved hand and proceed to measure a second raw material without changing or sanitizing his gloves.
We have reviewed your response to the FDA-483 dated March 27, 2012. You stated that you will provide training to your employees to ensure appropriate sanitization and cleaning standards are used during your manufacturing processes and that employee training will be documented in a training log. You also indicated that these issues are addressed in your SOP #09. However, your response is inadequate because you did not provide SOP #09 for us to evaluate and you provided no supporting documentation of the employee training. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
- Your firm failed to use utensils of appropriate design and construction to enable them to be suitable for their intended use and to be adequately cleaned and properly maintained, as required by 21 CFR 111.27(a). Specifically, on 1/31/2012, our investigator observed your employees use a brush and tape knife containing a partial product label to level and recapture dietary supplement ingredients during encapsulation of Magnesium capsules (b)(4) and (b)(4) L-Arginine (b)(4) at your Anza Avenue manufacturing facility. The tape knife had accumulated residue on the blade surface. The brush had a metal band between the handle and bristles that may not allow for adequate cleaning and sanitizing between and after each use. Our investigator was advised that these utensils were purchased from a retail hardware store, which suggests that they may not be food grade equipment that is so designed and of such material and workmanship as to be adequately cleanable. Also, there is no assurance that they are made of nontoxic material and designed to withstand the environment of their intended use in dietary supplement manufacturing.
We have reviewed your response to the FDA-483 dated March 27, 2012. You stated that you are updating and reviewing hand utensils for manufacturing processes and that you added new cleaning utensils for your production machines. Your response is inadequate because you did not specify what utensils were added or include any supporting documentation of your corrective actions. We will evaluate the adequacy of any proposed corrective action during our next inspection of your facility.
We also note that your firm includes expiration dates on the labels for your dietary supplement products, including your LunaSX Male Performance product. During the inspection, you provided no data supporting the expiration dates listed on these product labels. In addition, your accelerated stability data for component tablets of your (b)(4) 30 day dietary supplement packs indicate a two year expiration date. However, batch production records and finished (b)(4) 30 day product that our investigator observed on 1/31/12 and 2/1/12 at your Hancock Parkway facility indicate that you used a four year expiration date for your (b)(4) 30 day finished product. In addition, you provided no stability data for the Omega-3 capsules included in the packaged (b)(4) 30 day product. Any expiration date that you place on a product label should be supported by data that demonstrates the product’s shelf life [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007)].
- Your (b)(4) pediatric electrolyte solution product (b)(4) that you contract manufacture for (b)(4) is misbranded within the meaning of section 403(a) of the Act [21 U.S.C. § 343(a)] in that the labeling is false or misleading because the amount of sodium and potassium present is less than the amount declared on the label. Specifically, under 21 CFR 101.9(g)(4)(i), a product is misbranded if the nutrient content of the added nutrients sodium and potassium is not at least equal to the value for the nutrients declared on the label of the product. Your product label states that the product provides 975mg/serving of sodium and 719mg/serving of potassium. However, FDA laboratory analysis found the sodium content in this product to be 27.1% (original analysis) and 26.1% (check analysis) of the amount declared on the label. FDA laboratory analysis found the potassium content in this product to be 30.5% (original and check analysis) of the amount declared on the label.
- Further, your (b)(4) pediatric electrolyte solution product (b)(4) is misbranded within the meaning of sections 403(i)(2) and (k) of the Act [21 U.S.C. § 343(i)(2) and (k)], because the product bears or contains a chemical preservative(s) but fails to declare on the label and bear labeling stating that fact. In accordance with 21 CFR 101.4 and 21 CFR 101.22(j), ingredients in the product must be declared on the label and the label of a food to which a chemical preservative(s) is added must bear a label declaration stating both the common or usual name of the ingredient(s) and a separate description of its function, e.g., “preservative,” “to retard spoilage,” “a mold inhibitor,” “to help protect flavor” or “to promote color retention.” We have reviewed your formula batch record for this product and the product label associated with the batch. However, ingredients used in the manufacture of this product, specifically, sucralose, sodium benzoate, and potassium sorbate, are not declared on the finished product label with a separate description of their function as required.
- Your LunaSX Women’s Intimate product (b)(4) is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because it contains the ingredient, DHEA, that is not declared on the label, as required by 21 CFR 101.4.
Our inspection also revealed that the LUNA SX Water Base Lubricant, with claims including, but not limited to, “condom compatible,” is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 C.F.R. 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is available through the Internet at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether your product may be legally marketed.
In addition, please be advised that the (b)(4) Personal Lubricant Jelly, the (b)(4) Gel Lubricant, the (b)(4) Silicone Lubricant, and the (b)(4) Liquid Lubricant are devices under 201(h) of the Act, 21 U.S.C. § 321(h), because these products are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. These products are being marketed with claims including, but not limited to: “condom compatible” and “latex compatible.” These devices do not have an appropriate marketing authorization in effect.
Unapproved New Drugs
We also note that your website continues to promote your dietary supplement products for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. For example, our review of your website at www.creationsgarden.com in July 2012 found that you promote the “Bowel & Parasite Cleanse” and “Parasite Cleanse” products as drugs because the names of your products imply treatment in individuals with parasites. Your products are not generally recognized as safe and effective for the labeled uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. Under section 301(d) and 505(a) of the Act [21 USC §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your firm previously received a Warning Letter dated August 4, 2011 for the claims made on your website, www.creationsgarden.com, which caused your products to be unapproved new drugs under section 505(a) of the Act.
Furthermore, your “Bowel & Parasite Cleanse” and “Parasite Cleanse” 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 products safely for their intended uses. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their 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)].
This letter is not intended to be an all-inclusive list of violations at your facilities. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.
You should take prompt action to correct the violations specified above and prevent their reoccurrence. Failure to do so may result in enforcement action by FDA without further notice, including seizure and injunction.
Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Include in your response documentation to show that correction has been achieved. If you cannot complete all corrections within 15 working days, please state the reason for the delay and the date by which you will complete the corrections.
Please send your written response to this letter to:
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
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.
If you have any questions about this letter, please contact Marco S. Esteves, Compliance Officer, at 949-608-4439.
Alonza E. Cruse
cc: Ingeborg Small
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue - MS 7602
P.O. Box 997413
Sacramento, California 95899-7435