- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameYoon Chang
- Mission LLC
911 North 10th Place, Suite B
Renton, WA 98057-0009
- Issuing Office:
- Division of West Coast Inports
February 6, 2020
Re: CMS # 593118
Dear Mr. Yoon Chang:
On August 2 and 5, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Mission, LLC, 911 North 10th Place, Suite B, Renton, WA 98057-0009. We also conducted an inspection on July 17-18, 2018. These inspections were conducted to determine compliance with the requirements of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) and the FSVP implementing regulation in 21 CFR part 1 subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. You may find information relating to the FSVP regulation and your
responsibilities to comply with the regulation through links in FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals.
During our most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for your black tea imported from foreign supplier (b)(4)., located in (b)(4). Your firm did not have an FSVP for this product, or any food products which you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act. At the conclusion of the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated August 16, 2019. Your response included documents from the foreign manufacturer, (b)(4)., such as a HACCP Plan and hazard analysis for the imported black tea. We address your response below.
Your significant violations of the FSVP regulation are as follows: Your firm did not have FSVPs for the products that you import, including the black tea imported from foreign supplier (b)(4)., located in (b)(4). During our July 2018 inspection, we similarly found that you did not have FSVPs.
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is your responsibility to ensure that you are in compliance with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1 subpart L.
You should take prompt action to correct the above violations. If you do not promptly correct them, we may take further action. For instance, we may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of black tea imported from foreign supplier (b)(4), including placing the food from the identified foreign supplier on detention without physical examination (DWPE) when you import the product. You can find DWPE information relating to FSVP in Import Alert #99-41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act.
In addition to the above violations, we also have the following comments: In response to the Form FDA 483a, you provided FDA with a copy of your foreign supplier’s HACCP plan for black tea, which included a hazard analysis. To the extent that you intend to rely on the hazard analysis to meet your obligations under the FSVP regulation, we note that you did not provide FDA with any evidence that you documented your review of your foreign supplier’s hazard analysis as required per 21 CFR 1.504(d). You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis (21 CFR 1.504(d)). You did not submit your review and assessment of your supplier’s hazard analysis. We also note that a hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards, and physical hazards (21 CFR 1.504(b)(1)). A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury (21 CFR 1.500). Your foreign supplier’s hazard analysis lists “microbial growth,” but does not list specific microorganisms or pathogens. Some microorganism may be more resistant to processing steps used to achieve microbial reduction than others. Therefore, to adequately determine what hazards require a control, the hazard analysis should identify the relevant microorganisms or pathogens. We note that potential bacterial pathogens in tea may include Bacillus cereus, C. perfringens, pathogenic E. coli, Salmonella spp. and S. aureus. In addition, your foreign supplier’s hazard analysis does not identify mycotoxins as chemical hazards which are known or reasonably foreseeable. Mycotoxins are toxic metabolites produced by molds that infect food crops. Mold growth in susceptible products can occur in storage under improper temperature and humidity conditions. There have been reports of mycotoxins (aflatoxin and ochratoxin A) that are produced by certain species of Aspergillus molds in dried tea leaves. Mycotoxins are not easily destroyed by heat; therefore, mycotoxins that are present in the dried tea leaves can potentially end up in the finished tea beverage. There have been reports of very high levels of mycotoxins in tea. In addition, we note that meeting the hazard analysis requirements in 21 CFR 1.504 is not enough. The FSVP regulation also generally requires that you evaluate your foreign supplier’s performance (21 CFR 1.505) and conduct foreign supplier verification activities (21 CFR 1.506), among other requirements.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should address the specific things you are doing to correct these violations. You should include in your response documentation and information that would assist us in evaluating your corrections, (e.g., documentation of changes you made, such as a copy of your revised FSVP, records to demonstrate implementation of your FSVP, and any additional information that you wish to supply relevant to your compliance with the FSVP regulation). If you believe that you are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
Please send your reply to Food and Drug Administration, Attention: Deborah W. Hsu, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Deborah Hsu via email at email@example.com. Please reference CMS # 593118 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Dan R. Solis
Program Division Director
Division of West Coast Imports