- Delivery Method:
- Certified Mail
- Food & Beverages
Recipient NameSalwan (Sam) Shayota
- Express Trading International Inc.
401 B Street, Ste 2310
San Diego, CA 92101
- Issuing Office:
- Division of Southwest Imports
July 2, 2020
Re: CMS #606776
Dear Mr. Shayota,
On February 19, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection at 401 B Street, Suite 2310, San Diego, CA. We also conducted an inspection on July 17, 2018. This inspection was 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 Canned Coconut Milk and Aloe Vera Drink Pomegranate imported from your foreign supplier, (b)(4), located in (b)(4). Your firm did not have FSVPs for these products. 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 July 17, 2018 and our follow-up inspection on February 19, 2020, our investigator provided you each time with a Form 483a, citing FSVP observations.
You responded to the initial Form 483a on July 18, 2018, stating that you intended “to have a fully-developed FSVP in writing no later than September 1st, 2018.” On August 31, 2018, you stated that your FSVP would be prepared by October 1, 2018. We received your responses to the most recent Form 483a on March 5, 2020, April 8, 2020 and April 22, 2020. Your response on March 5 stated that your “[c]urrent estimated time of completion is about 6 weeks from now.” Your response on April 8 stated that your “pending timeframe for complete response is 6 weeks from now, hopefully.” Your response on April 22 stated that you “have been in process of getting specific HACCP plans from each supplier so that (b)(4) can crate a proper FSVP.” No further correspondence has been received to date.
These responses do not provide sufficient information to evaluate your plan or progress because you did not provide any supporting documentation.
Your significant violations of the FDVP 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 each of the following foods:
• Canned Coconut Milk imported from (b)(4), located in (b)(4).
• Aloe Vera Drink Pomegranate products 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.
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 canned coconut milk and Aloe Vera Drink Pomegranate, imported from (b)(4), located in (b)(4). We may place these foods from the identified foreign suppliers on detention without physical examination (DWPE) when you import these 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.
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: Alexander Lopez
Director, Compliance Branch
U.S. Food and Drug Administration
4040 North Central Expressway, Suite 300
Dallas, TX 7520
If you have any questions regarding this letter prior to your written response, you may contact Barbara Rincon, Compliance Officer at telephone number (619) 941-3691 or via email at Barbara.Rincon@fda.hhs.gov. Please reference CMS #606776 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Division of Southwest Imports