- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameJay S. Egami
- UCC Ueshima Coffee Company America Inc.
723 A Liggett Ave
San Francisco, CA 94129-1480
- Issuing Office:
- Division of West Coast Imports
January 29, 2021
Re: CMS #612006
Dear Mr. Jay S. Egami:
On August 27-28, September 1-3, 8-9 and 11, 2020, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically. We also conducted an inspection on May 23, 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 implementing FSVP regulation under 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 your UCC black coffee (ready-to-drink) and UCC green tea (ready-to-drink), imported from (b)(4); and UCC Hawaii Kona coffee (ready-to-drink) imported from (b)(4). You 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 the FSVP inspection, our investigator provided you with Form FDA 483a, FSVP Observations.
We acknowledge receipt of your three responses to the Form FDA 483a, including your stated intent to work with a consultant to address our concerns, a presentation by the consultant that describes an FSVP “compliance procedure” ranging from responding to the Form FDA 483a to “FSVP document preparation,” a list of milestones extending to February 2021 for completing tasks related to FSVP compliance, and general commitments to complete SOPs to implement various FSVP requirements. We are unable to fully evaluate your responses because you did not provide any written procedures or documentation of your FSVP activities to show that you have made corrections or developed FSVPs for the foods you import from your foreign suppliers. You also have not provided progress reports to FDA on the schedule indicated in your list of milestones.
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 FSVPs for each of the following foods:
a. UCC black coffee (ready-to-drink) imported from (b)(4);
b. UCC green tea (ready-to-drink) imported from (b)(4); and
c. UCC Hawaii Kona coffee (ready-to-drink) imported from (b)(4).
During our inspection you provided an audit certificate for your supplier (b)(4); however, you did not provide a record of your review of this document or explain how it would apply to your FSVP program. You also provided two other documents, an audit certificate and supplier questionnaire, but it was not clear that they were for one of the identified suppliers.
2. For thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods), with respect to those microbiological hazards that are controlled by following 21 CFR part 113, you must verify and document that the food was produced in
accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1). You did not verify and document that your products – UCC black coffee (ready-to-drink), UCC green tea (ready-to-drink), and UCC Hawaii Kona coffee (ready-to-drink) – low-acid canned foods, were produced in accordance with 21 CFR part 113, as required by 21 CFR 1.502(b)(1).
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 address the above violations. If you do not promptly 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 UCC black coffee (ready-to-drink) and UCC green tea (ready-to-drink), both imported from (b)(4); and UCC Hawaii Kona coffee (ready-to-drink) imported from (b)(4).
We may place products that appear to be adulterated or misbranded from the identified foreign suppliers on detention without physical examination (DWPE) when you import the products. You can find DWPE information relating to FSVP in Import Alert (b)(4). 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 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: Debbie Giang, 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 Debbie Giang via phone at (562) 256-9235 or via email at firstname.lastname@example.org. Please reference CMS # 612006 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Acting Program Division Director
Division of West Coast Imports