- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameCanh Huu Nguyen
- Ding Tea Balboa
5945 Balboa Ave.
San Diego, CA 92111-2711
- Issuing Office:
- Division of Southwest Imports
December 9, 2021
Re: CMS # 620269
Dear Mr. Nguyen:
On August 23 and September 16 through 17, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Ding Tea Balboa located at 5945 Balboa Ave., San Diego, CA 92111-2711. We also conducted an inspection on March 22, 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 foods 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 most recent inspection, our investigator provided you with a Form FDA 483a FSVP Observations.
We acknowledge receipt of your response to the FDA 483a dated September 18, 2021,which stated that you will get your FSVP plans ready in 1 year. We are unable to evaluate the adequacy of your response because you have not provided any supporting documentation or records demonstrating your planned or completed corrective actions. We also note that our most recent FSVP inspection follows a previous FSVP inspection in 2019, which demonstrated your firm’s failure to develop, maintain, and follow FSVPs.
In addition, we acknowledge that during the most recent inspection, you told the FDA investigator that you no longer import, and do not plan to import, any of the products covered in the inspection, including the Thai Tea Powder imported from (b)(4), located in (b)(4), the (b)(4) imported from (b)(4), located in (b)(4), and the Hazelnut Syrup imported from (b)(4), located in (b)(4). However, based on our review of your current shipping history, you imported the (b)(4) from (b)(4), located in (b)(4), and the Hazelnut Syrup from (b)(4), located in (b)(4), on September 14, 2021. Moreover, our review of your current shipping history found that you imported a tea product from (b)(4), located in (b)(4), between August 1, 2020 and July 31, 2021.
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 foods you import, including each of the following foods:
• Thai Tea Powder imported from (b)(4)
• (b)(4) imported from (b)(4), located in (b)(4)
• Hazelnut Syrup 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 you import for which you appear to be in violation of section 805. We may place the foods you import into the United States on detention without physical examination (DWPE) when you import the foods. 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)).
Additionally, we offer the following comment:
We note that, based on your sales volume, you may meet the definition of a “very small importer” under 21 CFR 1.500. If you meet the definition of a “very small importer” and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of “very small importer,” as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510 (see 21 CFR 1.512(b)(2)). In addition, for each food you import, you must obtain written assurance, before importing the food and at least every two years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (see 21 CFR 1.512(b)(3)(i)).
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 the foods you import 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: Rosa Linda Santos, Compliance Officer, US FDA, 7201 Main St., Suite 7200, Dallas, TX 75202. If you have any questions regarding this letter, you may contact CO Santos via email at email@example.com. Please reference CMS #620269 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Director, Southwest Imports