WARNING LETTER
OCM Group USA Inc.
MARCS-CMS 609106 —
October 16, 2020
Delivery Method:
United Parcel Service
Product:
Food & Beverages
Recipient:
OCM Group USA Inc.
16555 Gale Ave.
City of lndustry
,
CA
91745-1713
United States
jessiexie@ocmfocxls.com
Issuing Office:
Division of West Coast Import
United States
WARNING LETTER
October 16, 2020
Re: CMS # 609106
Dear Ms. Jie Y. Xie:
From May 15 through 19, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of OCM Group USA Inc. located at 16555 Gale Ave., City of Industry, CA 91745-1713. We also conducted an inspection on August 29, 2018. 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 Foreign Supplier Verification Program (FSVP) implementing 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 our most recent inspection, we found that you were not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import including, but not limited to, Crushed Chili imported from
(b)(4)
and
(b)(4)
(Sesame) imported from
(b)(4)
. During the inspection you told our investigator you did not have an FSVP for any of the food products you import. However, you also provided a one-page letter stating that “OCM Group USA, Inc. (hereafter (“OCM”) process [sic] the FSVP program as follow(s).” Your letter then indicated, among other things, that your firm would require and obtain: Quality Management Systems Certificates from manufacturers, Product Specifications and Laboratory Analysis of the products to be imported, HACCP System Certificates from the manufacturer, and certificates of analysis (COA) for
(b)(4)
to be imported. Attached to the letter were various documents including a HACCP and QMS certificates for
(b)(4)
(for seeds, nuts, pastry), and test reports for an unidentified product. We are unable to evaluate the adequacy of this response because you did not provide a record of your review of these documents or explain how they would apply to your FSVP program.
This letter reflecting your intentions mentions requirements for a hazard analysis and supplier evaluation, but there are no details regarding these or other FSVP requirements for any specific products. You did not provide any details or timeframes for when you will develop and implement FSVPs for any of the products you import. We note that, to the extent you may be trying to rely on the aforementioned HACCP and QMS certificates to fulfill your FSVP requirements, you must comply with the evaluation for foreign supplier approval and verification activities set forth in 21 CFR 1.505. Furthermore, in accordance with 21 CFR 1.506, you must establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under §1.505 (or, when necessary and appropriate, on a temporary basis from unapproved foreign suppliers whose foods you subject to adequate verification activities before importing the food). You must document your use of these procedures.
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 and the follow-up inspection in May 2020, our investigator provided you with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response via email dated June 24, 2020 in which you asked for 2 months to collect the required documents and develop an FSVP. As of the date of this letter, we have not received any further response to the FDA 483a, nor have you provided us with the required documents or FSVPs.
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 of the food products you import, including:
Crushed Chili, imported from
(b)(4)
(b)(4)
(Sesame), imported from
(b)(4)
The above violation is 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 products you import. We may place the food products you import on detention without physical examination (DWPE) when you import the 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.
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 revised 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 your products 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: Deborah W. Hsu, 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 Deborah Hsu via email at deborah.hsu@fda.hhs.gov. Please reference CMS # 609106 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 Import
Content current as of:
10/27/2020
Regulated Product(s)
Food & Beverages