WARNING LETTER
Don’t Run Out dba Public Goods
MARCS-CMS 626847 —
March 11, 2022
Delivery Method:
VIA EMAIL AND UNITED PARCEL SERVICE
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Morgan Hirsh
Recipient Title
CEO
Don’t Run Out dba Public Goods
85 Delancy Street Floor 3, Ste. 53
New York
,
NY
10002-3182
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
March 11, 2022
Re: CMS 626847
Dear Mr. Morgan Hirsch:
On November 23, 2021 through December 30, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Don’t Run Out dba Public Goods, located at 85 Delancy Street, Floor 3, Ste. 53, New York, NY 10002-3128. We also conducted an inspection on November 20, 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-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
(b)(4)
Ramen Noodles) you import from
(b)(4)
. Because of this significant violation, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the most recent 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 December 30, 2021.
Your significant violation of the FSVP regulation is as follows:
You did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and21 CFR 1.502(a). Specifically, you did not develop, maintain, and follow an FSVP for
(b)(4)
Ramen Noodles) from
(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.
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 products you import for which you appear to be in violation of section 805. We may place the
(b)(4)
Ramen Noodles) you import from
(b)(4)
on detention without physical examination (DWPE) when you import the food. 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: Feryal Ahmad, Compliance Officer, Division of Northeast Imports, ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) Feryal.Ahmad@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Ahmad via email at Feryal.Ahmad@fda.hhs.gov. Please reference CMS# 626847 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/
CAPT Nazmul Hassan
Program Division Director
Division of Northeast Imports
Content current as of:
05/03/2022
Regulated Product(s)
Food & Beverages