- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameJesus Adrian Rodriguez
Recipient TitleImport and Export Manager
- E&H Distributors LLC
4630 Border Village Rd Ste 4113
San Ysidro, CA 92173-3121
- Issuing Office:
- Division of Southwest Imports
November 04, 2020
Re: CMS # 610883
Dear Mr. Rodriguez:
On May 5, 2020 to August 4, 2020, the Food and Drug Administration (FDA) conducted a remote follow-up Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm E & H Distributors LLC, located at 6774 Calle De Linea, Suite 104/105, San Diego, CA 92154. We also conducted an initial inspection on September 12, 2017. 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/GuidanceRegulation/FSMA/ucm361902.htm
During the most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your (b)(4) soft tamarind flavored candy imported from your foreign supplier (b)(4) and (b)(4) candy imported from your foreign supplier (b)(4). You did not have FSVPs for these products or any food products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on September 12, 2017 and the follow-up inspection on August 4, 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
We have not received your response to the Form FDA 483a from the most recent follow-up inspection.
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, your firm did not develop an FSVP for each of the following foods:
• (b)(4) soft tamarind flavored candy imported from (b)(4)
• (b)(4) candy imported from (b)(4)
You initially told our investigator on May 5, 2020 that you did not have any FSVPs for any food products that you import and that you would later send them electronically. On May 15, 2020, you emailed our investigator a form that you purported to be your FSVP. However, the form is simply a document titled “Determining the FSVP Importer” that is not specific to your firm, your products, or your foreign suppliers. This document does not cover, even in part, an FSVP plan as required by 21 CFR 1.502(a) such that it provides adequate assurances that your foreign suppliers are producing each food you import in compliance with processes and procedures that provide at least the same level of public health protection as those in the FD&C Act.
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 the foods you import. We may place the foods 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 https://www.accessdata.fda.gov/cms_ia/importalert_1160.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.
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: Joseph Brady, Compliance Officer, Division of Southwest Imports, 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154.
If you have any questions regarding this letter, you may contact CO Brady via email at firstname.lastname@example.org. Please reference CMS # 610883 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Program Division Director
Division of Southwest Imports