- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Juan Manuel Ramirez
- Las Dos Californias Inc DBA Dulceria los Cuates
2155 Paseo De Las Americas
San Diego, CA 92154-7907
- Issuing Office:
- Division of Southwest Imports
Dear Mr. Juan Manuel Ramirez:
On October 19 through October 27, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Las Dos Californias Inc DBA Dulceria Los Cuates located at 2155 Paseo De Las Americas, Suite 33, San Diego, CA 92154. We also conducted inspections on May 9, 2019 and January 17, 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 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 inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your response dated November 15, 2021, and we address your response below.
Your response to the FDA 483a stated that you “acquired assistance from (b)(4) to develop your FSVPs for 1. (b)(4) manufactured by (b)(4) and 2. (b)(4) Chamoy Botella, manufactured by (b)(4). We estimate to begin providing the requested FSVP records by 8 weeks approximately." You also provided a signed “Food Safety Services Agreement” between your company and (b)(4) dated November 11, 2021, and an invoice from (b)(4) dated November 12, 2021, which shows the charges associated with the development of FSVPs for two suppliers. On December 21, 2021, you stated that you were working on the FSVPs but they were not yet ready. To date, no additional FSVP documents beyond what you provided during the inspection have been received by FDA.
Your significant violations of the FSVP regulation are as follows:
1. You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, you did not develop an FSVP for the foods indicated in the attached list, including each of the following foods you import:
• (b)(4) (tamarind flavor candy) imported from (b)(4) located in (b)(4)
• Toasted Pumpkin Seeds imported from (b)(4) located in (b)(4)
2. You must conduct a hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504(a). Although you may meet your requirement to determine whether there are any hazards requiring a control by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). Specifically, during the inspection, you provided a copy of your “Foreign Supplier Verification Program (FSVP) (b)(4) which included the flowchart process and the hazard analysis for your (b)(4) Chamoy product performed by your foreign supplier, (b)(4) However, you did not provide documentation that you reviewed and assessed your foreign supplier’s hazard analysis as required by 21 CFR 1.504(d). Similarly, during the inspection, you provided HACCP documents for one other foreign supplier that was not the subject of this inspection, (b)(4) located in (b)(4) but you also did not provide documentation that you reviewed and assessed those documents.
3. You did not approve your foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document your approval, as required by 21 CFR 1.505(b). Specifically, for your foreign supplier, (b)(4) you did not document your evaluation of the foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a)(2), or document your approval of this supplier, as required by 21 CFR 1.505(b).
4. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document your use of these procedures, as required by 21 CFR 1.506(a)(1). Specifically, you have not established written procedures for approving your foreign supplier (b)(4)
5. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import, as required by 21 CFR 1.506(b). Specifically, you did not establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to your (b)(4) Chamoy product imported from (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)).
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: Emmanuel Dominguez, Compliance Officer, Division of Southwest Imports, 216 W. Village Blvd., Suite 107, Laredo, TX 78041. If you have any questions regarding this letter, you may contact Emmanuel Dominguez via email at Emmanuel.Dominguez@fda.hhs.gov. Please reference CMS # 625844 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
One Main Place
1201 Main Street, Suite 7200
Dallas, TX 75202