WARNING LETTER
Fella Group LLC
MARCS-CMS 625512 —
February 25, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Jesus F. Felix Miranda
Recipient Title
Owner
Fella Group LLC
24 Seedling
Irvine
,
CA
92618-8860
United States
Issuing Office:
Division of West Coast Imports
United States
February 25, 2022
WARNING LETTER
Re: CMS # 625512
Dear Mr. Felix:
On December 10, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection at FELLA GROUP LLC, 24 Seedling, Irvine, CA 92618-8860. We also conducted an inspection on July 28, 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/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 were 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 January 6, 2022, and we address your response below.
Your response stated that you would develop an FSVP plan for all imported food products imported by Fella Group LLC, and the time required to develop the FSVP plan would be between January 6, 2022 to December 15, 2022. You provided the same response to your initial inspection in which you provided a time frame of August 8, 2020 to July 31, 2021. To date, you have not made adequate corrective actions or provided sufficient FSVP documentation for the foods you import.
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 each of the following foods:
Mayocoba Beans imported from
(b)(4)
Chick Peas (Garbanzo Beans) imported from
(b)(4)
Rustic Salad Dressing imported from
(b)(4)
and
any other foods you import
The above violation is 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: William Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Ste 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS # 625512 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:
03/15/2022
Regulated Product(s)
Food & Beverages