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  5. Barohup Inc. - 681282 - 08/28/2024
  1. Warning Letters

WARNING LETTER

Barohup Inc. MARCS-CMS 681282 —

Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Eunji Kong, President/Chief Executive Officer
Recipient Title
Aidan Kong, Owner
Barohup Inc.

309 Rathbourne
Irvine, CA 92620-0237
United States

Issuing Office:
Division of West Coast Imports

United States

August 28, 2024

WARNING LETTER

Re: CMS # 681282

Dear Mrs. Eunji Kong:

On January 17 and February 22, 2024, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of Barohup Inc. located at 309 Rathbourne, Irvine, CA 92620. We also conducted an inspection on July 21 through August 21, 2023. 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

During the inspection we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for the foods you import. 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 responses dated March 15, 2024, and April 22, 2024. Your response described your intended corrective actions including discontinuing importation from specific foreign suppliers. We are unable to evaluate the adequacy of this corrective action because you have not provided any supporting documentation demonstrating your planned or completed corrective actions.

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 most of the foods you import from the foreign suppliers indicated in the attached list.

Your written response dated April 22, 2024, provided documentation of an evaluation of Korean pears imported from (b)(4) in (b)(4). However, we cannot fully evaluate the adequacy of the corrective actions. Your written response does not clearly document whether another entity, using a qualified individual, conducted the evaluation of your foreign supplier on your behalf (21 CFR 1.505(d)) and your written response did not include documentation of your approval of the foreign supplier (21 CFR 1.505(b)). The adequacy of your reported corrective actions will be verified during our next inspection.

2. You did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on an evaluation conducted under 1.505, as required by 1.506(a)(1). Specifically, on July 4, 2023, you did not approve your foreign supplier (b)(4) based on an evaluation of the foreign supplier conducted under 1.505. The records you provided demonstrate that, based on your verification activities, you determined that it was not “safe to import mushrooms from this supplier.” However, on September 20, 2023, you continued to import enoki mushrooms from this foreign supplier. During the inspection, you told the investigator that you decided to import from this supplier because you needed a supplier of enoki mushrooms, among other reasons. However, you were unable to provide documentation that you established and followed written procedures to ensure that foods are only received from approved foreign suppliers or that you established and followed written procedures to use unapproved foreign suppliers on a temporary basis based on adequate verification activities before importing the food, in accordance with 21 CFR 1.506(a)(1).

3. You did not meet the requirement to promptly reevaluate your foreign supplier’s performance and the risk posed by a food, and document the concerns associated with those risks, when you became aware of new information about those risk factors, in accordance with 21 CFR 1.505(c)(1). Specifically, on November 30, 2023, when you became aware of the private laboratory positive Listeria monocytogenes results for your enoki mushrooms from your foreign supplier, (b)(4), you did not promptly reevaluate the concerns associated with your foreign supplier’s performance and the risk posed by the enoki mushrooms. During the inspection, you explained to our investigator that you would no longer import from this foreign supplier. However, no documentation supporting this determination was provided. If you determine that the concerns associated with importing a food from a foreign supplier have changed, you must promptly determine (and document) whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities conducted under 1.506 need to be changed.

4. You did not promptly investigate to determine whether your FSVP is adequate and, when appropriate, modify your FSVP after you determined by means other than the verification activities conducted under 1.506 or a reevaluation conducted under 1.505(c) or (d), that a foreign supplier of food that you import does not produce food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 or 419 (21 USC 350g or 350h) of the FD&C Act, as applicable, and the implementing regulations, or produces food that is adulterated under section 402 (21 USC 342) or misbranded under section 403(w) (21 USC 343(w)), if applicable, of the FD&C Act, as required by 21 CFR 1.508(b). Specifically, you did not promptly investigate and document your investigation to determine whether your FSVP is adequate when you were made aware of a positive finding of Listeria monocytogenes in enoki mushrooms you imported from (b)(4). During the inspection, you were unable to provide documentation that you undertook such an investigation when you received laboratory results of positive Listeria monocytogenes for your enoki mushrooms along with an FDA notice of detention on November 30, 2023. You must document any investigations, corrective actions, and changes to your FSVP that you undertake in accordance with 21 CFR 1.508(b).

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 USC 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)).

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 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 working 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: Dan Simonsen, Compliance Officer Division of West Coast Imports, 1 World Trade Center, Ste. 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact Compliance Officer Dan Simonsen via email at Daniel.Simonsen@fda.hhs.gov. Please reference CMS # 681282 on any documents or records you provide to us and on the subject line of any email correspondence you send to us.

Sincerely,
/S/

Dr. Kathleen Turner
Program Division Director
Division of West Coast Imports

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