WARNING LETTER
Fitsum Ghebremichael Amare
MARCS-CMS 617082 —
October 20, 2021
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Fitsum Ghrebremichael Amare
Recipient Title
Owner
Fitsum Ghebremichael Amare
978 81st Ave
Oakland
,
CA
94621-2512
United States
Issuing Office:
Division of West Coast Imports
United States
October 20, 2021
WARNING LETTER
Re: CMS # 617082
Dear Mr. Fitsum Ghrebremichael Amare:
On May 13, 2021, June 2, 2021, and June 24, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Fitsum Ghrebremichael Amare located at 978 81st Ave, Oakland, CA 94621. We also conducted an inspection on June 11 through 12, 2019. 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-supplierverification-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 have not received your response to the Form FDA 483a issued on June 24, 2021.
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 any foods that you import, including:
• Teff Grain imported from
(b)(4)
located in
(b)(4)
• Teff Grain imported from
(b)(4)
located in
(b)(4)
• Teff Grain and Brown Teff Grain imported from
(b)(4)
located in
(b)(4)
• Brown Teff Grain 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.
In addition, based on the information available to the agency, it appears you may meet the definition of a very small importer, as defined in 21 CFR 1.500. If you are a very small importer and you choose to comply with the modified requirements in 21 CFR 1.512, you must document that you meet the definition of very small importer as required per 21 CFR 1.512(b)(1)(i). If this section applies and you choose to comply with the requirements in paragraph (b) of this section, you also are required to comply with the requirements in sections 1.502, 1.503, and 1.509, but you are not required to comply with the requirements in sections 1.504 through 1.508 or 1.510. In addition, for each food you import, you must obtain written assurance, before importing the food and at least every 2 years thereafter, that your foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 of the FD&C Act, if either is applicable, and the implementing regulations, and is producing the food in compliance with sections 402 and 403(w) (if applicable) of the FD&C Act (21 CFR 1.512(b)(3)(i)).
Furthermore, under section 1.509 of the FSVP regulation (21 CFR 1.509), the FSVP importer must provide its name, electronic mail (i.e., email) address, and unique facility identifier (UFI) recognized as acceptable by FDA electronically when filing entry with U.S. Customs and Border Protection. The FSVP importer’s Data Universal Numbering System (DUNS) number is the UFI that is recognized as acceptable by FDA. DUNS numbers are assigned and managed by Dun & Bradstreet.
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: Lin Liu, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Mr. Lin Liu via email at lin.liu@fda.hhs.gov. Please reference CMS # 617082 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.
Sincerely,
/S/
Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports
Content current as of:
11/09/2021
Regulated Product(s)
Food & Beverages