Inspections, Compliance, Enforcement, and Criminal Investigations

KPC Products Inc 6/20/18

 

  

Black HHS-Blue FDA Logo

 

Division of Human and Animal Food
Operations West 5
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
Fax: 949-608-4417 

 
 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
 
June 20, 2018          
                                                                                                                                   WL # 548695
Mr. Michael Tsay
Operations Supervisor
16 Goddard
Irvine, CA 92618-4600
 
Dear Mr. Tsay:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, KPC Products, Inc., located at 16 Goddard Irvine, CA 92618-4600 on December 14, 19, and 20, 2017. 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 your dietary supplement product Tong Qiao Huo Xue Tang/ Persica Ligusticum Combination 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 it has been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. 
 
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 February 22, 2018, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on 12/20/2017. 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 component specifications for each component that you use in the manufacture of a dietary supplement in that you failed to establish an identity specification, as required by 21 CFR 111.70(b)(1), and you failed to establish component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, at the time of the inspection, you had not established the required component specifications.
 
We have reviewed your response, dated February 22, 2018, and determined that your response fails to demonstrate the sufficiency of your corrective actions. In your response, you stated that you established a component specification for identity for your Jia Wei Xiao Yao San (Bupleurum Peony Formula) product. Your specification for identity appears to be by color (with an acceptance criteria of “(b)(4)”). A specification for identity may include more than one attribute (72 FR 34842); for a botanical, color alone does not adequately ensure the identity of the component because of decreased reliability, or in those instances where misidentification of botanicals is known to occur. Note that 21 CFR 111.320(a) requires you to verify that laboratory examination and testing methodologies are appropriate for their intended use; and 21 CFR 111.320(b) requires you to identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met. In addition, your response did not provide documentation that you have established component specifications that are necessary to ensure that specifications for the purity, strength, and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
 
Once you have established these specifications, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, unless you petition the agency under 21 CFR 111.75(a)(1)(ii), and the agency exempts you from such testing, as required by 21 CFR 111.75(a)(1)(i). You must confirm the identity of other components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). You must ensure that the tests and examinations that you use to determine whether specifications are met are appropriate, scientifically valid methods (21 CFR 111.75(h)(1).)
 
2.    You failed to establish product specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of dietary supplement, to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Specifically, at the time of the inspection, you had not established identity, purity, strength, and composition specifications for your finished products.
 
We have reviewed your response, dated February 22, 2018, and determined that your response fails to demonstrate the sufficiency of your corrective actions. In your response, you stated that you established a finished product specification for identity for your Jia Wei Xiao Yao San (Bupleurum Peony Formula) product. Your specification for identity appears to be by color (with an acceptance criteria of “(b)(4)”). Specifically, “identity” of a dietary supplement refers to the dietary supplement’s consistency with the master manufacturing record and/or that it is the same as described in the master manufacturing record [see 72 FR at 34803]. Color alone does not adequately ensure the dietary supplements’ consistency with the master manufacturing record to ensure the quality of the dietary supplement. In addition, your response did not provide documentation that you have established product specifications for purity, strength, and composition.
 
Once you have established these specifications, you must verify that your finished batch of the dietary supplement meets specifications, as required by 21 CFR 111.75(c). You must ensure that the tests and examinations that you use to determine whether specifications are met are appropriate, scientifically valid methods (21 CFR 111.75(h)(1).) You must verify that the laboratory examination and testing methodologies are appropriate for their intended use, as required by 21 CFR 111.320(a). You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met, as required by 21 CFR 111.320(b).
 
Misbranded Dietary Supplements
 
1.    The Tong Qiao Huo Xue Tang, Chai Hu Gui Zhi Gan Jiang Tang, and Xiao Feng San 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:
  • The Chai Hu Gui Zhi Gan Jiang Tang product label declares the dietary ingredient scute, but this is not the standardized common name or Latin binomial noted in the reference Herbs of Commerce. The standardized common name for scute is Chinese skullcap.
  • The Tong Qiao Huo Xue Tang product label declares the dietary ingredients persica, carthamus, and ligusticum, but the Latin binomials are Prunus persica, Carthamus tinctorius, and Ligusticum wallichii, respectively. The Tong Qiao Huo Xue Tang product label declares the dietary ingredient red peony, but the standardized common name is Chinese peony.
  • The Xiao Feng San product label declares the dietary ingredients tangkuei (dang gui), arctium, and alractylodes (cang zhu), but these are not the standardized common names or Latin binomials noted in the reference Herbs of Commerce. The standardized common names are dong quai, burdock, and cang-zhu atractylodes, respectively 
2.    The Tong Qiao Huo Xue Tang, Chai Hu Gui Zhi Gan Jiang Tang, and Xiao Feng San products are 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.
 
We offer the following comment:
 
1.    The Xiao Feng San product label identifies the part of the plant from which the dietary ingredient akebiae is derived as “caulis.” The identification of plant parts (when listed) should be in English and not Latin. Furthermore, the label identifies the part of the plant from which the dietary ingredient schizonepeta is derived as “plant,” but this should be specified as “entire plant.”
 
2.    The Tong Qiao Huo Xue Tang, Chai Hu Gui Zhi Gan Jiang Tang, and Xiao Feng San product labels contain information in two languages, but do not repeat all the required information in both languages. If a product label contains any representation in a foreign language or foreign characters, all required label information should appear in the foreign language.
 
This letter is not an 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.
 
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 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.
 
 
Your response should be sent to:
 
 
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Compliance Branch, HAF Division West 5, HFR-PA150
19701 Fairchild
Irvine, CA 92612
 
If you have any questions about the content of this letter, please contact Sara J. Dent Acosta, Compliance Officer, at 619-941-3767. Include Special Identifier “Dent Acosta FEI # 3003228434” on all correspondence.
 
Sincerely,
/S/ 
Darla Bracy, Director
Office of Human and Animal Foods
Division 5 West
US Food and Drug Administration
 
 
Cc: 
Benson Yee
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435

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