WARNING LETTER
Global Commodities Corp.
MARCS-CMS 607103 —
June 03, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ronald Yu & Mrs. Cathy C. Yu
Global Commodities Corp.
23759 Eichler Street, Suite G
Hayward
,
CA
94545-2783
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
June 3, 2020
Re: CMS # 607103
Dear Mr. Ronald Yu & Mrs. Cathy C. Yu:
On February 27, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) follow-up inspection at Global Commodities Corp., located at 23759 Eichler Street, Suite G, Hayward, CA 94545. We also conducted an initial inspection of September 12, 2017. These inspections were conducted to determine your firm’s 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 will 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 your FSVPs for Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves imported from
(b)(4)
, Philippines; and Boy Bawang Mixed Nuts Snacks – Garlic imported from KSK Food Products, Philippines. Your firm did not have FSVPs for these products. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on September 12, 2017 and the follow-up inspection on February 27, 2020, our investigator provided you in each instance a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response sent via email dated March 5, 2020 where you included documents from your foreign supplier,
(b)(4)
, Philippines, such as a HACCP plan entitled “Bottled Tropical Fruit Preserves” dated May 10, 2019 (includes Sugar Palm Fruit and Macapuno String and others) and three SGS Certificates. You also included your document titled, “FSVP Foreign Supplier Verification Activity(ies) Worksheet Example” for “Macapuno Strings” and “Kaong” products. We are unable to evaluate the adequacy of your response because you did not provide details as to how the documents meet the requirements of the FSVP regulation. We address your response in more detail 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, your firm did not develop an FSVP for Boy Bawang Mixed Nuts Snacks-Garlic manufactured by KSK Food Products, Philippines.
2. For a low-acid canned food not subject to further processing, you did not verify and document the food was produced accordance with the low-acid canned food regulations (part 113), or with respect to all matters not controlled by part 113, you did not have an FSVP, as required by 21 CFR 1.502(b)(1). Specifically, your firm did not document compliance with 21 CFR part 113 or otherwise develop an FSVP for Buenas Kaong Red Sugar Palm Fruit in syrup and Macapuno String in Syrup Preserves manufactured by
(b)(4)
, Philippines.
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.
You should take prompt action to correct the above violations. If you do not promptly correct them, 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 that you import including Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves manufactured by
(b)(4)
located in Philippines and Boy Bawang Mixed Nuts Snacks – Garlic manufactured by KSK Food Products located in Philippines. We may place the foods you import on detention without physical examination (DWPE) when you import these products. 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.
In addition to the above violations, we also have the following comments. In response to the Form FDA 483a, you provided FDA with a copy of your foreign supplier’s HACCP plan and SGS Certificates for Food Safety System Certification (ISO 22000), Good Manufacturing Practice (Codex Alimentarius), and HACCP Codex Alimentarius. To meet your obligation under the FSVP regulation, you did not provide FDA with evidence that you conducted a hazard analysis as required by 21 CFR 1.504(a). You may meet your requirement to conduct a hazard analysis, as required under 21 CFR 1.504(a), by reviewing and assessing your supplier’s hazard analysis and documenting your review and assessment of that hazard analysis (21 CFR 1.504(d)). You did not submit your supplier’s hazard analysis or your review and assessment of your supplier’s hazard analysis. Further, the FSVP regulation also generally requires that you evaluate your foreign supplier’s performance and document your approval, as required by 21 CFR 1.505; and conduct foreign supplier verification activities as required by 21 CFR 1.506, among other requirements. You did not provide FDA with evidence that you evaluated or approved your suppliers or conducted verification activities.
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 these 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 send your reply to Food and Drug Administration, Attention: David Serrano, 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. Serrano via email at: david.serrano@fda.hhs.gov. Please reference CMS # 607103 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
Content current as of:
06/30/2020
Regulated Product(s)
Food & Beverages