- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameXianmin Guan
- California Terra Garden Inc.
6055 E. Washington Blvd., Suite 200
Commerce, CA 90040
- Issuing Office:
- Division of West Coast Imports
November 10, 2021
Re: CMS #616499
Dear Mr. Guan:
On May 11, 2021 through June 8, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of California Terra Garden Inc. located at 6055 E. Washington Blvd., Suite 200 Commerce, CA 90040. We also conducted an inspection on January 8, 2020. 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.
Our current inspection was initiated due to recent recall events associated with mushroom products imported by you from your foreign suppliers. Specifically, retail samples of enoki mushroom products imported from your foreign supplier, (b)(4), resulted in positive findings for Listeria monocytogenes by the Michigan Department of Agriculture and Rural Development (MDARD). In response to MDARD’s findings, on April 20, 2021 a voluntary recall of enoki mushrooms was initiated. Additionally, retail samples of enoki mushroom products imported from your foreign supplier, (b)(4), resulted in positive findings for Listeria monocytogenes by the Massachusetts Department of Public Health (MDPH). In response to MDPH’s findings, on May 6, 2021 the voluntary recall of enoki mushroom products was expanded. Further, during our FSVP inspection, you were notified by the California Department of Public Health on May 27, 2021, that retail sample of seafood mushroom product, imported from your foreign supplier, (b)(4), tested positive for Listeria monocytogenes. You conducted a voluntary recall of the imported seafood mushroom products on May 28, 2021.
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 following foods you import: fresh enoki mushrooms imported from (b)(4) located in (b)(4), king oyster mushrooms imported from (b)(4) located in (b)(4), and fresh seafood mushrooms imported from (b)(4) located in (b)(4). Because of these significant violations, your firm is not in compliance with section 805 of the FD&C Act.
At the conclusion of the FSVP inspection, our investigator provided you with a Form FDA 483a, FSVP Observations. We acknowledge receipt of your response dated June 22, 2021, and we address your response below.
Your significant violations of the FSVP regulation are as follows:
• 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. In approving your foreign suppliers and determining the appropriate supplier verification activities, you did not consider the foreign suppliers’ 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 king oyster mushrooms imported from (b)(4), enoki mushrooms imported from (b)(4), and fresh seafood mushrooms imported from (b)(4), are raw agricultural commodities covered under 21 CFR Part 112, Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Rule), but your supplier evaluation and approval did not consider the suppliers’ compliance with the requirements of the Produce Safety Rule.
Your response to the FDA 483a dated June 22, 2021 states that you suspended and canceled orders from your suppliers of enoki and seafood mushrooms and that you intend to “[r]eview the supplier approval process, impose tighter control, and perform more testing.” We are unable to review the adequacy of your response because you did not describe how you would determine that your suppliers are producing the foods in accordance with the Produce Safety Rule. You also did not provide any information regarding your review of processes and procedures related to produce safety for your suppliers of other imported covered produce, such as king oyster mushrooms.
• Your supplier verification activities did not provide adequate assurance that the hazards requiring a control in the foods you import have been significantly minimized or prevented, as required by 21 CFR 1.506(c). FDA has determined that the biological hazards in covered produce require a control, and compliance with the requirements in the Produce Safety Rule significantly minimizes or prevents the biological hazards. However, your verification activities did not include verifying your suppliers’ compliance with the Produce Safety Rule or documenting processes or procedures that provide at least the same level of public health protection as required by the Produce Safety Rule.
Your response to the FDA 483a dated June 22, 2021 states that you are reviewing your supplier approval program and reevaluating vendors in (b)(4); however, we cannot evaluate the adequacy of your response because you did not provide any details about this review or your findings. Your response also states that suppliers provided you with certificates, including the Quality Management System Certificate and the HACCP System Certificate, which are commonly issued certificates in (b)(4); however, it is unclear if you have evaluated these certifications to assess whether your suppliers are growing and packaging the food in accordance with the Produce Safety Rule. Furthermore, in your response, you state that you are “requesting the GLOBAL GAP which has the same standard as US,” but you did not provide any documentation regarding these standards or comparing them to the level of public health protection provided by the requirements in the Produce Safety Rule. Your response also states that you plan to sample (b)(4) from your suppliers; however, details of your proposed testing plan were not included in your corrective action response. Finally, although you included a report from (b)(4) in your response, we are unable to assess how it relates to the FSVP requirements without an English translation.
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 enoki mushrooms imported from your foreign supplier, (b)(4), king oyster mushrooms imported from your foreign supplier, (b)(4) and seafood mushrooms imported from your foreign supplier, (b)(4). We may place the foods 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)). In addition to the above violations, we also have the following comment:
We note that under 21 CFR 1.506(d)(2), when a hazard in a food will be controlled by the foreign supplier and is one for which there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals, you must conduct or obtain documentation of an onsite audit of the foreign supplier before initially importing the food and at least annually thereafter, unless you make an adequate written determination that, instead of such initial and annual onsite auditing, other supplier verification activities and/or less frequent onsite auditing are appropriate to provide adequate assurances that the foreign supplier is producing the food in accordance with the relevant food safety standards. Your response to the FDA 483a dated June 22, 2021 states that “[b]ecause of the COVID-19 pandemic, no site audit could be performed. It could only be resumed when there is no travel restriction. So, sampling and testing will play an important role.” Your response further states that you are requesting testing reports from suppliers, as well as sampling and testing (b)(4) to “make sure the result is acceptable.” We note that FDA has issued guidance for industry concerning alternative verification activities when onsite audits are temporarily impracticable because of COVID-19. The “Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency” is available at https://www.fda.gov/media/136142/download. FSVP importers should resume onsite audits within a reasonable period of time after it becomes practicable to do so.
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 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 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 provide an English translation of any records that you provide in a language other than English in order to facilitate our review.
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 # 616499 on any documents or records you provide to us and/ or within the subject line of any email correspondence you send to us.
Dr. Kathleen Turner Program Division Director
Division of West Coast Imports
cc: Ms. Sareth S. Yip, FSVP Manager