WARNING LETTER
Coastal Fresh Farms, Inc.
MARCS-CMS 629333 —
May 11, 2022
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Leonard T. Cole
Recipient Title
President
Coastal Fresh Farms, Inc.
3625 E Thousand Oaks Blvd
Ste 243
Westlake Village
,
CA
91362-3500
United States
Issuing Office:
Division of West Coast Imports
United States
Dear Mr. Cole:
On January 31 through February 9, 2022, the Food and Drug Administration (FDA) conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Coastal Fresh Farms, Inc. located at 3625 E Thousand Oaks Blvd Ste 243, Westlake Village, CA 91362-3500. We also conducted an inspection on August 14 – 21, 2020. 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/foodsafety- modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-foodhumans-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 have not received your response to the Form FDA 483a issued on February 9, 2022.
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, maintain, and follow an FSVP for any foods that you import, including:
Coriander imported from
(b) (4)
;
Green onion imported from
(b) (4)
;
and
Parsley curly imported from
(b) (4)
During our August 2020 inspection, you provided a one-page Standard Operating Procedure (SOP) titled “FSMA-VENDOR APPROVAL,” dated January 23, 2020, and various audit reports from your foreign suppliers. However, the documents that are relevant to an FSVP are incomplete, and you did not provide a record of your review of the relevant documents or explain how they would apply to your FSVP program. Thus, these documents do not constitute an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). During the most recent inspection, you did not provide any documents related to an FSVP. On February 2, 2022, you sent us an email indicating your intent to meet with a food safety consultant to “discuss putting together an FSVP program.” Therefore, at the conclusion of this inspection we found that you were not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import.
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:
You import raw agricultural commodity produce, which is “covered produce” as defined in 21 CFR 112.3. Your FSVP must demonstrate your supplier is in compliance with the requirements of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (21 CFR part 112).
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 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: Nabeela J. Chaudhry, Compliance Officer, Division of West Coast Imports, 1 World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Nabeela Chaudhry via email at nabeela.chaudhry@fda.hhs.gov. Please reference CMS #629333 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/
Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports
Content current as of:
05/24/2022
Regulated Product(s)
Food & Beverages