- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameXianmin Guan
- Ventura Terra Garden Inc.
4440 Olivas Park Drive #A
Ventura, CA 93001-4310
- Issuing Office:
- Division of West Coast Imports
July 29, 2020
Re: CMS # 608649
Dear Mr. Guan:
On April 15-17, 20-21 and 29, 2020, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of FSVP records that you submitted to FDA electronically for your firm, Ventura Terra Garden Inc., 4440 Olivas Park Drive #A, Ventura, CA 93001. This remote inspection was 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.
The inspection was initiated due to enoki mushrooms from (b)(4) being associated with a Listeria monocytogenes outbreak. Ms. Yip, your food safety manager, provided a copy of a voluntary recall press release by Forest Mushroom Food Inc., dba Guan’s Mushroom Co., dated March 23, 2020. The press release stated that Forest Mushroom was recalling "all cases of its 200g/7.05 ounce packages of Enoki Mushroom (Product of Korea) because it has the potential to be contaminated with Listeria monocytogenes…" Ms. Yip stated that your firm imports mushrooms (b)(4). In addition, FDA collected three (3) samples of enoki mushrooms (b)(4) and that analysis revealed the presence of Listeria monocytogenes.
During our inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for your fresh packaged enoki mushrooms imported from your foreign supplier (b)(4). You did not have an FSVP for this product. Additionally, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the documents you presented as your FSVPs for your enoki mushrooms. Because of this significant violation, your firm is not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspection, our investigator emailed you a copy of Form FDA 483a, FSVP Observations.
We have not received your response to Form FDA 483a. We acknowledge receipt of your email response dated May 21, 2020 wherein you indicated that your "company is working on the hazard analysis and revising the SOPs for approved foreign suppliers. However, we need more time to complete the corrective actions and it is expected to complete by end of May." As of the date of this letter, we have not received a response and therefore, we are unable to evaluate the adequacy of your response.
Your significant violations of the FSVP regulation are as follows:
1. You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control in accordance with 21 CFR 1.504(a). You may rely on the hazard analysis of your foreign supplier to meet your obligations under the FSVP regulation, however, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazards analysis as required per 21 CFR 1.504(d). 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 required by 21 CFR 1.504(d).
2. An onsite audit of your foreign supplier, (b)(4), did not consider an applicable food safety regulation, in accordance with 21 CFR 1.506(e)(1)(i)(B). Specifically, your third-party "Audit Checklist Report" (b)(4) dated April 4, 2019, for your enoki mushrooms imported from (b)(4)., did not include the Food Safety Modernization Act (FSMA) Produce Safety Rule as part of the criteria.
3. You did not promptly document your review and assessment of the results of a verification activity that was conducted by another entity in accordance with 21 CFR 1.506(e)(3). Specifically, you did not have documentation that you reviewed and assessed the result of third-party (b)(4) audit for your Enoki mushroom imported from, (b)(4).
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 enoki mushrooms, imported from your foreign supplier (b)(4).
We may place the food from the identified foreign supplier 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 Actor 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 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: Juliane Jung-Lau, Compliance Officer, Division of West Coast Imports, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Ms. Jung-Lau via email at Juliane.Jung-Lau@fda.hhs.gov. Please reference CMS # 608649 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Dan R. Solis
Program Division Director
Division of West Coast Imports
Ms. Sareth S. Yip, FSVP Manager
Ventura Terra Garden Inc.
4440 Olivas Park Drive #A
Ventura, CA 93001-4310