- Perfect Source Natural Products Inc.
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
August 10, 2016
WL # 39-16
Mr. Andy D. Yurcho, Owner and President
Perfect Source Natural Products Inc.
401 S Acacia Ave
Fullerton, CA 92831-4753
Dear Mr. Yurcho:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Perfect Source Natural Products Inc., located at 401 S Acacia Ave., Fullerton, California on February 25, 29, March 1, 3, 4, and 14, 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, we reviewed the labeling of your dietary supplement products collected during the inspection of your facility. Based on our review, your Performance Plus dietary supplements are misbranded under Section 403 of the Act [21 U.S.C. § 343] because they do not comply with FDA’s labeling regulations under 21 CFR Part 101. You can find the Act and FDA regulations through links on the FDA’s home page at http://www.fda.gov
We have received your written response dated April 1, 2016, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on March 14, 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 adequate product specifications for the identity and purity of the finished batch of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, you state that you provide your contract manufacturers with finished product specifications for the Perfect Source products. However, you have not established finished product specifications for identity and purity for your Fiber Plus, CC Tabs, Supreme Greens, and Performance Plus dietary supplement products. We note that you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
We acknowledge your response included revised finished product specifications for strength, composition, limits on contaminants (heavy metals and microbiological), and physical properties which appear to relate to identity; however, to the extent these physical properties are meant to be your finished product specifications for identity, we consider them to be inadequate. Having identity specifications for only one dietary ingredient - dietary fiber for Fiber Plus, papain content for CC Tabs, aloe vera for Performance Plus, and alfalfa for Supreme Greens - is not adequate to determine the dietary supplements products’ identity. Each of these dietary supplement products contains multiple other dietary ingredients. The establishment of identity specifications for only one of these dietary ingredients is not adequate to determine the dietary supplement products’ consistency with the associated master manufacturing records (MMRs) and/or labeling declarations. We also note that the specification “Presence” is inadequate for determining the identity of the papain dietary ingredient in your CC Tabs product and the alfalfa dietary ingredient in your Supreme Greens product.
Further, you have failed to establish adequate purity specifications. The specifications of “not less than (b)(4) pure Proprietary Blend as listed above in the Formula” for Fiber Plus, “not less than (b)(4) pure Proprietary Blend as listed above in the Formula” for CC Tabs, “not less than (b)(4) pure Proprietary Blend as listed above in the Formula” for Performance Plus, and “not less than (b)(4) pure Proprietary Blend as listed above in the Formula” for Supreme Greens stated in the revised finished product specifications included in your response are not adequate specifications for the purity of these dietary supplement products. Your response does not indicate which ingredient(s) in the proprietary blends would need to be tested or which testing parameters to use to determine how these specifications are met. Moreover, the Supreme Greens dietary supplement product label describes the dietary ingredient soy lecithin as being “97% phospholipids” and “99% oil free.” The finished product specification of “not less than (b)(4) pure Proprietary Blend as listed above in the Formula” does not ensure these quality levels of soy lecithin in the finished batch of dietary supplement.
2. You state that finished product testing for the Perfect Solution products is conducted by your contract manufacturer. However, the testing records you provide do not show that the contract manufacturer verified, for a subset of finished dietary supplement batches identified through a sound statistical sampling plan (or for every finished batch), that the finished batch of the dietary supplement meets product specifications for identity, purity, strength and composition of the finished batch of the dietary supplement, as required by 21 CFR 111.75(c). Specifically, there is no verification that the Supreme Greens, lot number (b)(4), CC Tabs, lot number (b)(4), Fiber Plus, lot number (b)(4), and Performance Plus, lot number (b)(4), dietary supplement products met finished product specifications for identity, purity, strength, and composition of the finished batch of the dietary supplement.
Your response states that it is not possible to utilize a scientifically valid test method to test and verify every specification set in your multi-ingredient dietary supplements. It may not be possible to directly verify every specification you have set; however, per 21 CFR 111.75(c)(1,) a manufacturer must select one or more specifications that, if tested or examined, would verify that the production and process control system is producing a dietary supplement that meets all product specifications. Furthermore, a manufacturer must provide adequate documentation of its basis that compliance with the chosen specifications will ensure that the finished batch of the dietary supplement meets all product specifications, and quality control personnel must review and approve such documentation [21 CFR 111.75(c)(3); 111.105(d)]. Your response did not include adequate documentation describing the basis of the manufacturer’s testing of one dietary ingredient, for example, alfalfa for your Supreme Greens, papain for your CC Tabs, fiber for your Fiber Plus, and aloe vera for your Performance Plus dietary supplement products, to ensure that your dietary supplement products meet your finished product specifications and product label declarations.
Per 21 CFR 111.75(d)(1) and (2), a manufacturer may exempt a product specification from the verification requirements if it determines that the selected specifications under paragraph (c)(1) are not able to verify the product meets the exempted specification and there is no scientifically valid method for testing or examining the exempted product specification at the finished batch stage. If the manufacturer exempts certain finished product specifications from testing, it must document why, for example, any component and in-process testing, examination, or monitoring, and any other information, will ensure that such exempted product specification is met without verification through periodic testing of the finished batch; and the quality control personnel must review and approve this documentation.
Your response states that by confirming the product’s identity, the purity, strength, and composition is also confirmed, without any tests on the finished product. However, you fail to account for factors that can impact the strength and composition of each of the specifications in your finished products such as mixing, uniformity, product loss, etc. You are basing your finished product specifications being met for strength on achieving 100% yield and mixing uniformity; however your response did not include other test results or information from the manufacturer conducting the testing that demonstrates your products meet all your finished product specifications.
As a firm that performs certain manufacturing operations (e.g., receipt of certain raw materials, establishing finished product specifications, packaging, and labeling) and that contracts with other manufacturers to manufacture, package, or label dietary supplements that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how these activities are performed so that you can make decisions related to whether the products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg. 34752, 34790 (June 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of dietary supplements into interstate commerce for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that your products are in compliance with dietary supplement CGMP requirements.
Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, 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 with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations.
You 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). You must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). The quality control personnel must ensure that your 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). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement [21 CFR 111.127(h) and 111.140(b)(2)].
Dietary Supplement Labeling Violations
Your Performance Plus dietary supplement product is misbranded under section 403 of the Act [21 U.S.C. §343] because the product does not comply with the labeling requirements for dietary supplements. The inspection revealed the following violations of labeling requirements for dietary supplements:
1. Your Performance Plus dietary supplement product is misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that the label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement. “Domestic address or domestic phone number” means a complete address or phone number. The label for this product does not include a complete address or phone number.
2. Your Performance Plus dietary supplement product is misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the nutrition information does not comply with 21 CFR 101.36. For example:
- The label declares a quantitative amount of zero for (b)(2)-dietary ingredients total fat and cholesterol and fail to comply with 21 CFR 101.36(b)(2)(i). Specifically, the (b)(2)-dietary ingredients must not be declared if they are present in amounts that can be declared as zero in accordance with 21 CFR 101.9(c).
- The label states the product contains calcium and iron, among other (b)(2)-dietary ingredients and is listed incorrectly below the supplement facts panel. These (b)(2)-dietary ingredients must be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero (e.g., amounts of 2 or more percent of the RDI for vitamins and minerals) in nutrition labeling of foods in accordance with 101.9(c) to comply with 21 CFR 101.36(b)(2).
- The label lists both dietary ingredients with an established Reference Daily Intake (RDI) (e.g., Vitamin C) and dietary ingredients for which FDA has not set a Daily Reference Value (DRV) or RDI (e.g., aloe vera) as defined under 21 CFR 101.36(b)(2) and (b)(3), respectively. For example, the label lists Vitamin C with other dietary ingredients under 21 CFR 101.36(b)(3). In order to comply with 21 CFR 101.36(b)(2)(i)(B), the label must lists Vitamin C with the (b)(2)-dietary ingredients.
3. Your Performance Plus dietary supplement product is misbranded within the meaning of sections 403(q)(5)(F) and 403(i)(2) of the Act [21 U.S.C. §§ 343(q)(5)(F) and 343(i)(2)] in that it is fabricated from two or more ingredients, but the 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. For example:
- (b)(4) is stated as an ingredient in the product’s finished product specifications collected during the inspection and submitted in your response to the Form FDA 483 but this excipient is not declared on the product’s label in accordance with 21 CFR 101.4(g).
- The revised specifications submitted in your response to the Form FDA 483 lists (b)(4) indented under “Sea Life Blend,” but these ingredients are not declared on the product label. Where the name of the solvent used is not included in the nutrition label, it is required to be listed in the ingredient statement in accordance with 21 CFR 101.4(g). Furthermore, the product label lists ingredients within the Sea Life Blend that do not correspond with the revised product specifications.
- The product label fails to declare all the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4(h). The Latin binomial is required for the ingredients in the proprietary blend, because those ingredients are not found in Herbs of Commerce.
- The product label’s “Other ingredients” lists “Black Cherry,” but fails to declare that this ingredient is a flavor and specify whether it is an artificial or natural flavor. The revised specifications submitted in your response to the Form FDA 483 lists the ingredient (b)(4).
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 have the following comments:
- The Performance Plus dietary supplement product’s Supplement Facts Panel appears to list the proprietary blend ingredients in alphabetical order. Dietary ingredients contained in the proprietary blend shall be declared in descending order of predominance by weight.
- The Performance Plus dietary supplement product declares the dietary ingredient aloe vera in an amount of 14.85 grams per serving although the product’s revised finished product specifications submitted in your response states the product’s “Label Claim” as “13.80” grams.
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.
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.
Your response should be sent to:
CAPT Larry Howell
Acting Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Marco Esteves, at 949-608-4439, or via e-mail to Marco.Esteves@fda.hhs.gov.
CDR Steven E. Porter, Jr.
Los Angeles District Director
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