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October 21, 2021

Re: CMS #615164

Dear Mr. Liu:

On May 12-13, 2021 and May 18, 2021, the Food and Drug Administration conducted a Foreign Supplier Verification Programs (FSVP) inspection at Golden Medal Mushroom Inc., 1181 Sacramento St, Los Angeles, CA 90021. This inspection was initiated, in part, as a follow-up to the Michigan Department of Agriculture and Rural Development (MDARD) finding of Listeria monocytogenes (L. monocytogenes), a human pathogen, in a product sample of enoki mushrooms distributed by your firm. You imported the mushrooms from your foreign supplier, (b)(4). The mushrooms were subject to a Class I recall on April 22, 2021. We placed enoki mushrooms grown by (b)(4) on Import Alert #99-23, “Detention Without Physical Examination of Produce Due to Contamination With Human Pathogens” (b)(4). This inspection was conducted to determine your 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.

During the inspection, we found that you were not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import, including enoki mushroom imported from (b)(4). Your firm did not have FSVPs for these foods. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.

At the conclusion of the inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your response dated May 22, 2021, and we address your response below.

Your response stated, “there is not a FSVP program currently in place at Golden Medal Mushroom Inc.” and that you will develop and implement an FSVP program within six (6) months of the date of your response. We evaluated your response and find it inadequate because
you did not provide further details or documentation regarding implementation of an FSVP program for the product you continue to import.

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, you did not develop an FSVP for any of the foods you import, including each of the following foods:

• Enoki mushroom imported from (b)(4)
• King oyster mushroom imported from (b)(4)
• Hon shimeji (white) 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.

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 the food you import for which you appear to be in violation of section 805. We may place the foods you import into the United States 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 have the following comment.

We note that the requirements for corrective actions in the FSVP regulation are that importers must take appropriate corrective actions if they determine that a foreign supplier of a food they import does not produce the food in compliance with the relevant food safety requirements (21 CFR 1.508(a)). This determination could be based on a review of consumer, customer, or other complaints related to food safety, the verification activities conducted under §1.506 or §1.511(c), a reevaluation of the risks posed by the food and the foreign supplier's performance conducted under §1.505(c) or (d), or any other relevant information you obtain (21 CFR 1.508(a)). The appropriate corrective actions will depend on the circumstances but could include discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding have been adequately addressed (21 CFR 1.508(a)). You must document any such corrective actions taken in accordance with section 1.508 (21 CFR 1.508(a)).

It appears that you did not take appropriate corrective action in accordance with 21 CFR 1.508(a) after you became aware that a food that you imported was adulterated under section 402 of the FD&C Act (21 U.S.C 342). Specifically, you were notified by MDARD on April 20, 2021 that enoki mushrooms you imported from (b)(4) were positive for L. monocytogenes. Although you recalled the contaminated enoki mushrooms on April 22, 2021, you also received additional shipments of enoki mushrooms packaged in 200g, 150g, and 100g bags on or about April 26, 2021 from (b)(4) under entry # (b)(4). You told our investigator that you had samples from this shipment tested by a third party lab for L. monocytogenes. You stated on April 30, 2021 that the third party laboratory reported the 150g bags of enoki mushrooms were negative for L. monocytogenes but the 200g and 100g bags of enoki mushrooms were positive for L. monocytogenes. You distributed the 150g bags of enoki mushrooms received on April 26, 2021, although there was no way to distinguish these enoki mushrooms from those packed in 100g and 200g bags, such as a different lot/batch number or best by date. You also received a shipment of enoki mushrooms packaged in 200g, 150g, and 100g bags on May 6, 2021 from (b)(4) under entry # (b)(4). You held this shipment intact at your firm. FDA rescinded the release of both of these shipments on May 7, 2021 and collected samples on May 10 and May 14, 2021, respectively.

FDA isolated L. monocytogenes from the following six enoki mushroom samples collected from both shipments, including the 150g bags of enoki mushrooms you received on April 26, 2021 and later distributed:

• Entry # (b)(4), Enoki mushrooms 200 g/7.05 oz. (FDA sample 1161785)
• Entry # (b)(4), Enoki mushrooms 150 g/5.29 oz., (FDA sample 1161789)
• Entry # (b)(4), Enoki mushrooms 100 g/3.5 oz., (FDA sample 1161790)
• Entry # (b)(4), Enoki mushrooms 200 g/7.05 oz., (FDA sample 1162099)
• Entry # (b)(4), Enoki mushrooms 150 g/5.29 oz., (FDA sample 1162103)
• Entry # (b)(4), Enoki mushrooms 100 g/3.5 oz., (FDA sample 1162105)

You destroyed the remaining enoki mushrooms from entry # (b)(4) on July 27, 2021 and the enoki mushrooms from entry # (b)(4) were destroyed on September 3, 2021. We acknowledged that you told our investigator that you would request (b)(4) to update their labels to include a lot number, conduct testing of each shipment prior to shipment, and provide certificates of analysis. However, you did not provide any supporting documentation to demonstrate these actions.

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 will 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 the foods you import 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: Lydia S. Chan, Compliance Officer, 1201 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding this letter, you may contact Lydia Chan via email at lydia.chan@fda.hhs.gov. Please reference CMS #615164 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/

Kathleen Turner, DVM
Program Division Director
Division of West Coast Imports