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December 20, 2021

WARNING LETTER

FEI: 3009136393

Re: CMS # 622995

Dear Mr. Huang,

On November 8-18, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Teahouse Tapioca and Tea Inc. located at 8181 Commerce Park Dr Ste 716, Houston TX 77036-7424. We also conducted an inspection on May 8, 2019. 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 implementing FSVP 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 the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, Mango Powder Mix imported from foreign supplier (b)(4) located in (b)(4), Green Apple Syrup imported from (b)(4) located in (b)(4), and Medium Tapioca imported from (b)(4) located in (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection in November 2021, our investigator provided you with a Form FDA 483a, FSVP Observations.

We acknowledge receipt of your response dated November 24, 2021, in which you stated that you do not currently have an FSVP Plan in place and you “plan to correct this by looking into taking the FSPCA Preventive Controls for Human Food Certificate Training courses as well as looking into having a third party to help.” The timeline you gave to have an FSVP Plan in place is November 2022. FDA sent an informal communication letter on December 9, 2021, noting that your response is insufficient, including because it lacks any detail as to what specific tasks have been/are to be performed, and by whom each task is to be performed. You replied on December 17, 2021, stating you “initiated [an] agent in (b)(4) to start the process on 12/16/2021” and you will provide an explanation on what you are planning and “have a better timeline as to when the (b)(4) Agent can have the necessary documents in place.” You did not provide any additional details or documentation demonstrating you have taken corrective action.

Your significant violations of the FSVP regulation are as follows:

You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, you did not develop an FSVP for any of the food products you import, including:

• Mango Powder Mix imported from foreign supplier (b)(4) located in (b)(4)
• Green Apple Syrup imported from (b)(4) located in (b)(4)
• Medium Tapioca imported from (b)(4) located in (b)(4).

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.

This letter notifies you of our concerns and provides you an opportunity to address them. If you do not adequately address this matter, 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 the food products you import for which you appear to be in violation of section 805. We may place the food products you import on detention without physical examination (DWPE) when you import the products. 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 (21 U.S.C. 331(zz)).

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 any 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 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 working 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: Attention: Kendra J. Vieira, Compliance Officer, 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. If you have any questions regarding this letter, you may contact Kendra J Vieira via email at Kendra.Vieira@fda.hhs.gov.

Please reference CMS # 622995 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.

Sincerely,
/S/

Todd Cato
Division Director
Division of Southwest Imports