WARNING LETTER
Golden Bridge Gourmet, Inc. DBA Golden Bridge Enterprises
MARCS-CMS 640718 —
January 03, 2023
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Onnik (nmi) Guzelses
Recipient Title
Vice President
Golden Bridge Gourmet, Inc. DBA Golden Bridge Enterprises
8040 San Fernando Rd
Sun Valley
,
CA
91352-4001
United States
goldenbr321@cs.com
Issuing Office:
Division of West Coast Imports
United States
January 3, 2023
WARNING LETTER
Re: CMS # 640718
Dear Mr. Onnik (nmi) Guzelses:
On July 18, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Golden Bridge Gourmet, Inc. DBA Golden Bridge Enterprises located at 8040 San Fernando Rd., Sun Valley, CA 91352-4001. We also conducted an inspection on February 13, 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 the foods you import. Because of these significant violations, your firm is 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 responses dated September 16, 2022, which consisted of several documents from your foreign suppliers
(b)(4)
, located in
(b)(4)
, and
(b)(4)
, located in
(b)(4)
. Although we requested English translations on October 3, 2022, you did not provide translations for all documents. We were unable to fully evaluate these documents for compliance with the FSVP regulation. In your response, you also provided statements that you prepared after receipt of the Form FDA 483a, indicating that you approved the importation of specified foods from your foreign suppliers,
(b)(4)
, located in
(b)(4)
, and
(b)(4)
, located in
(b)(4)
, based on your review of the hazard analysis and the production flow chart they provided for each product. You stated that you consider your verification process complete, and that you will reevaluate each product in three years. We further address your response below.
Your significant violations of the FSVP regulation are as follows:
1. 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 the foods indicated in the attached list, including, but not limited to, the following foods you import:
Bread, cookies, biscuits and wafers manufactured by
(b)(4)
, located in
(b)(4)
Cookies, biscuits, wafers, pastry and bread sticks manufactured by
(b)(4)
, located in
(b)(4)
Spaghetti and noodles manufactured by
(b)(4)
, located in
(b)(4)
Chutney, candy, chocolates manufactured by
(b)(4)
, located in
(b)(4)
Bread sticks manufactured by
(b)(4)
, located in
(b)(4)
Cookies, biscuits, and wafers manufactured by
(b)(4)
, located in
(b)(4)
Biscuits, bread, cookies, and cakes manufactured by
(b)(4)
, located in
(b)(4)
Tomato (dried), asparagus, mixed vegetable, and relish manufactured by
(b)(4)
, located in
(b)(4)
2. You must approve your foreign suppliers on the basis of an evaluation of your foreign supplier’s performance and the risk posed by the food, in accordance with 21 CFR 1.505(a), for the products you import. We acknowledge your responses to the Form FDA 483a, indicating that you have documented evaluation and approval of two foreign suppliers based on a review of the hazard analysis and flow chart related to specific foods. However, in approving your foreign suppliers and determining the appropriate supplier verification activities, you did not consider the foreign supplier’s procedures, processes, and practices related to the safety of the food, as required by 1.505(a)(1)(iii)(A). Moreover, your evaluation did not consider applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance with those regulations, as required by 21 CFR 1.505(a)(1)(iii)(B). Specifically, your Le Sfogliette Dorate Biscuit, imported from
(b)(4)
in
(b)(4)
, and Black Olives and Unseasoned Black Olive Paste, imported from
(b)(4)
in
(b)(4)
, are foods covered under 21 CFR Part 117, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Control Requirements). However, your supplier evaluation and approval documents did not demonstrate consideration of the supplier’s compliance with the Preventive Control Requirements.
3. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, you did not establish written procedures for ensuring that appropriate supplier verification activities are conducted in accordance with 21 CFR 1.506(b), and you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). Your email responses dated September 16, 2022, included documents titled, “Verification Procedures Page,” stating that you decided to import your Le Sfogliette Dorate Biscuits, Black Olives, and Unseasoned Black Olive Paste products after reviewing the hazard analyses and flow charts provided by the foreign suppliers, that the “verification process is complete”,” and that you “could reevaluate within 3 years.” Your responses also included four documents entirely in a foreign language labeled “
(b)(4)
,” “
(b)(4)
,” “
(b)(4)
,” and “
(b)(4)
,” as well as a copy of an audit report in a foreign language, partially translated to English, for your supplier
(b)(4)
, located in
(b)(4)
. The documents you provided do not demonstrate your determination that the activities performed were appropriate verification activities, as required per 1.506(d)(1)(i). Further, you did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing food and periodically thereafter, as required by 21 CFR 1.506(e). Specifically, you did not document your determination or performance of appropriate supplier verification activities for
(b)(4)
, located in
(b)(4)
, or
(b)(4)
, located in
(b)(4)
.
With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor and considers applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States). You must also promptly review and assess any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)). For your foreign supplier
(b)(4)
in
(b)(4)
, as mentioned above, you provided a copy of an audit report primarily in a foreign language, that states in part, “FSSC 22000,” dated March 3, 2022, conducted by auditor,
(b)(6)
, and that was conducted to the scope of “design and products of table olive, olive oil, olive paste.” However, this document is only partially translated into English, and there is no information regarding whether the audit considered applicable FDA food safety regulations, as required per 1.506(e)(1)(i)(B). Further, you did not document your review of the results of this audit, using a qualified individual, as required by 1.506(e)(3).
4. You must make all records required under this subpart available promptly to an authorized FDA representative, upon request, for inspection and copying. Upon FDA request, you must provide within a reasonable time an English translation of records maintained in a language other than English, as required by 21 CFR 1.510(b)(1). However, you did not provide an English translation of the following FSVP documents attached to your September 16, 2022, response to the FDA Form 483a, even after our October 3, 3022 request for the referenced documents in English: hazard analysis (partially translated into English) for the Le Sfogliette Dorate Biscuits, imported from
(b)(4)
; hazard analysis, flow chart, and copies of documents entirely in a foreign language that appear to relate to the importation of Black Olives and Unseasoned Black Olive Paste from
(b)(4)
in
(b)(4)
. To date you have still not provided the requested translation of these documents.
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 from the identified foreign suppliers 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)).
We also offer the following comment:
During the inspection,
(b)(6)
, Import Manager was described as the firm’s contact for FSVP compliance. In your first email response to the FDA Form 483a, dated September 16, 2022, you included several records, such as a hazard analysis and flow chart, which you indicated you had reviewed prior to approving the importation of Le Sfogliette Dorate Biscuit from
(b)(4)
, located in
(b)(4)
. Your second email response, also dated September 16, 2022, included documents, such as a hazard analysis and flow chart, which you stated you had reviewed prior to approving the importation of Black Olives and Unseasoned Black Olive Paste from
(b)(4)
, located in
(b)(4)
. However, you did not provide FDA with training records or certificates of FSVP course completion for the personnel who made this determination. Note that a qualified individual must develop your FSVP and perform FSVP activities, and a qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities, as required by 21 CFR 1.503(a).
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, 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: Sandra K. Wangen Compliance Officer, Division of West Coast Imports, 949 Market St, Suite 602, Tacoma, WA 98402. If you have any questions regarding this letter, you may contact Sandra K. Wangen via email at sandra.wangen@fda.hhs.gov. Please reference CMS # 640718 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:
03/07/2023
Regulated Product(s)
Food & Beverages