WARNING LETTER
GW FOOD USA Inc.
MARCS-CMS 624967 —
March 09, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
David Chong Hsin Cheng
Recipient Title
General Manager
GW FOOD USA Inc.
10928 Weaver Avenue, Suite C
South El Monte
,
CA
91733-2784
United States
Issuing Office:
Division of West Coast Imports
United States
March 09, 2022
WARNING LETTER
Re: CMS # 624967
Dear Mr. David Chong Hsin Cheng:
On November 30 through December 2, 2021, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of GW FOOD USA Inc., located at 10928 Weaver Ave., Suite C, South El Monte, CA 91733. We also conducted an inspection on May 7-8, 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/GuidanceRegulation/FSMA/ucm361902.htm
.
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 Form FDA 483a, FSVP Observations. We have not received your response to the Form FDA 483a issued on December 2, 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, maintain, and follow an FSVP for any of the foods that you import, including:
Organic Soya
(b)(4)
and Organic Soya
(b)(4)
imported from
(b)(4)
located in
(b)(4)
Seaweed & Fish Chip imported from
(b)(4)
located in
(b)(4)
During the most recent inspection, you provided records for one of your foreign suppliers, which you identified as
(b)(4)
located in
(b)(4)
. You initially presented the records to FDA in
(b)(4)
. During the close-out meeting, one of your staff members used Internet software to generate an English translation. However, the firm name on the translated documents is
(b)(4)
, located in
(b)(4)
, which does not match the name of any of the foreign suppliers covered in this inspection. The translated documents included a Standard Operating Procedure for Sanitation, Standard Operating Procedure for Warehousing Control, & Equipment Management Procedure. We are unable to evaluate the adequacy of this response because you did not provide your review of these documents or how they would apply to your FSVP for any of your products.
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)).
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 days, you should explain the reason for your delay and state when you will correct any remaining violations. Please provide an English translation of any records that you provide in a language other than English in order to facilitate our review.
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 # 624967 on any documents or records you provide to us and in 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:
03/22/2022
Regulated Product(s)
Food & Beverages