So while the importer did have a FSVP in place and they did have paperwork from that supplier, they did not verify performance.
"The records for your (b)(4), included third party audit certificates dated (b)(4); customer letter dated 30/01/2025; egg pasteurization declaration dated 26/09/2024; manufacturer’s declaration dated 02/10/2024; heat treatment for egg products dated 6 Giugno 2024; and a (b)(3)(A). However, you did not document your review and assessment of these records, or an evaluation of your foreign suppliers’ performance and the risk posed by a food conducted under 21 CFR 1.505(a), as required by 21 CFR 1.505(b)."
"..before importing a food from a foreign supplier you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities before importing a food from a foreign supplier, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor. Additionally, for food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States), in accordance with 21 CFR 1.506(e)(1)(i)(B). "I think this is a common issue with regulations in general. Companies feel compliance is just collecting the paperwork without understanding and then implementing meaningful verification. The goal of the regulation is that companies do more than collect the paperwork, but ensure that the supplier is performing.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eurobread-inc-dba-first-harvest-705728-07312025
Eurobread Inc. dba First Harvest
MARCS-CMS 705728 — July 31, 2025
Recipient:
Mr. Jeremy L. Perez
President
Eurobread Inc. dba First Harvest
1200 S Rogers Cir Suite 8
Boca Raton, FL 33487-5707
United States
Issuing Office:
Division of Southeast Imports
United States
July 31, 2025
WARNING LETTER
Re: CMS # 705728
Dear Mr. Jeremy L. Perez:
On February 2, through February 7, 2025, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Eurobread Inc. doing business as First Harvest, located at 1200 S Rogers Circle, Boca Raton, FL 33487. This 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.
During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for your FSVPs for the foods you import including, but not limited to, Mini Patisseries from foreign supplier (b)(4), and (b)(4) from foreign supplier (b)(4) from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
The inspection was initiated in response to a multistate and binational outbreak investigation involving Salmonella Enteritidis infections linked to (b)(4)-brand mini pastries manufactured by your foreign supplier, (b)(4) of (b)(4). Mini Patisseries were subject to a Class 1 recall, initiated on January 17, 2025. The recall was in response to the Canadian Food Inspection Agency (CFIA)’s outbreak investigation.
We placed Mini Patisserie RTE pastries from your foreign supplier, (b)(4) of (b)(4), on Import Alert #99-19, “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella,” on March 14, 2025. You may view this alert at: https://www.accessdata.fda.gov/CMS_IA/importalert_263.html.
Additionally, we placed all RTE foods from your foreign supplier, (b)(4) of (b)(4), on Import Alert #99-43, “Detention Without Physical Examination of Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on April 4, 2025. You may view this alert at: https://www.accessdata.fda.gov/CMS_IA/importalert_1168.html.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated February 28, 2025, from your consultant (b)(6), (b)(7)(C). You stated that you will be retaining a Qualified Individual to implement your Foreign Supplier Verification Program and that you had obtained documentation from certain foreign manufacturers. Your response included a letter addressing each Form FDA 483a observation and several attached documents. We address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirement to evaluate your foreign supplier’s performance and the risk posed by the food, as required by 21 CFR 1.505(a) and document your approval of your foreign suppliers based on this evaluation, as required by 21 CFR 1.505(b) for your Mini Patisseries from your foreign supplier (b)(4) and (b)(4) from your foreign supplier (b)(4) located in (b)(4). Under 21 CFR 1.505(a), you must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. During our inspection, you provided several records that you said you obtained from your distributor, (b)(4), located in (b)(4). The records for your Mini Patisseries from (b)(4), included a (b)(3)(A), a one-page Safety Food Certificate that declared compliance with “Reg. CE 852/04 (Food hygiene)” (which appears to be a European Union standard) dated 2024-04-02; and a data sheet for Mini Pastries from (b)(4) dated 02/10/2024. The records for your (b)(4), included third party audit certificates dated (b)(4); customer letter dated 30/01/2025; egg pasteurization declaration dated 26/09/2024; manufacturer’s declaration dated 02/10/2024; heat treatment for egg products dated 6 Giugno 2024; and a (b)(3)(A). However, you did not document your review and assessment of these records, or an evaluation of your foreign suppliers’ performance and the risk posed by a food conducted under 21 CFR 1.505(a), as required by 21 CFR 1.505(b).
Your response dated February 28, 2025, stated that FSVP procedures have been established to include conducting an evaluation or reviewing evaluations conducted by third parties to determine your foreign supplier’s performance and risk posed by a food. You also stated that you will not be importing from (b)(4) in the future, and you were advised that this company will no longer be in business. To the extent these statements are considered to represent that you reevaluated your supplier (b)(4), you must document your evaluation including that you determined it is no longer appropriate to continue to import the food from your supplier, per 21 CFR 1.505(c)(1).
Your response further added that (b)(4) has been audited by (b)(4) and the audit reports were reviewed by your consultant, (b)(6), (b)(7)(C), and found to be in compliance with food standards. However, neither the audits represented by the certificates provided during our inspection nor your consultant’s review considered the relevant food safety regulation for your (b)(4), which are the preventive controls requirements under 21 CFR part 117. In your evaluation, you did not consider your foreign supplier’s performance according to the applicable foods safety regulation, the preventive controls requirements under 21 CFR part 117, as required by 21 CFR 1.505(a)(1)(iii)(B).
2. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, before importing a food from a foreign supplier you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities before importing a food from a foreign supplier, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor. Additionally, for food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States), in accordance with 21 CFR 1.506(e)(1)(i)(B). You must also promptly review and assess the results of any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)(3)).
Specifically, you did not document your determination or performance of appropriate supplier verification activities before importing Mini Patisseries from your foreign supplier (b)(4), or (b)(4) from your foreign supplier (b)(4), as required by 21 CFR 1.506(d) and 21 CFR 1.506(e). Although your response included written procedures titled, “Evaluation and Approval of Foreign Suppliers FSVP,” you did not provide documentation of your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d).
Further, while you obtained several documents as described above, including a Safety Food Certificate dated 2024-04-02 and data sheet for (b)(4) dated 02/10/2024, and third-party audit certificates dated 27 March 2024 and 2024-03-28 for (b)(4), these records do not indicate that applicable FDA food safety regulations were considered (preventive controls requirements under 21 CFR part 117). Further, during our inspection and before importing the food from your foreign suppliers, you did not promptly review and assess any third-party audit that constitutes a verification activity, or document your review and assessment (21 CFR 1.506(e)(3)).
We acknowledge that your response dated February 28, 2025 stated you would stop importing from (b)(4), and your consultant described a review and assessment of the audit reports described above for (b)(4). We will continue to assess the adequacy of your corrective actions in our next inspection.
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 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 the foods you import for which you appear to be in violation of section 805 of the FD&C Act. We may place the foods 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 #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 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: Coral del Mar Lopez, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Rd. Suite #100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Lopez via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS No. 705728 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/
Sherea Dillon
Acting Program Division Director
Division of Southeast Imports
WARNING LETTER
Re: CMS # 705728
Dear Mr. Jeremy L. Perez:
On February 2, through February 7, 2025, the U.S. Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection of Eurobread Inc. doing business as First Harvest, located at 1200 S Rogers Circle, Boca Raton, FL 33487. This 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.
During the inspection, we found that you are not in compliance with the requirements of 21 CFR part 1, subpart L for your FSVPs for the foods you import including, but not limited to, Mini Patisseries from foreign supplier (b)(4), and (b)(4) from foreign supplier (b)(4) from (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
The inspection was initiated in response to a multistate and binational outbreak investigation involving Salmonella Enteritidis infections linked to (b)(4)-brand mini pastries manufactured by your foreign supplier, (b)(4) of (b)(4). Mini Patisseries were subject to a Class 1 recall, initiated on January 17, 2025. The recall was in response to the Canadian Food Inspection Agency (CFIA)’s outbreak investigation.
We placed Mini Patisserie RTE pastries from your foreign supplier, (b)(4) of (b)(4), on Import Alert #99-19, “Detention Without Physical Examination of Food Products Due to the Presence of Salmonella,” on March 14, 2025. You may view this alert at: https://www.accessdata.fda.gov/CMS_IA/importalert_263.html.
Additionally, we placed all RTE foods from your foreign supplier, (b)(4) of (b)(4), on Import Alert #99-43, “Detention Without Physical Examination of Ready-To-Eat Human Food Products That Appear To Have Been Prepared, Packed, Or Held Under Insanitary Conditions,” on April 4, 2025. You may view this alert at: https://www.accessdata.fda.gov/CMS_IA/importalert_1168.html.
At the conclusion of the inspection, our investigator provided you with a Form FDA 483a, FSVP Observations.
We acknowledge receipt of your response dated February 28, 2025, from your consultant (b)(6), (b)(7)(C). You stated that you will be retaining a Qualified Individual to implement your Foreign Supplier Verification Program and that you had obtained documentation from certain foreign manufacturers. Your response included a letter addressing each Form FDA 483a observation and several attached documents. We address your response below.
Your significant violations of the FSVP regulation are as follows:
1. You did not meet the requirement to evaluate your foreign supplier’s performance and the risk posed by the food, as required by 21 CFR 1.505(a) and document your approval of your foreign suppliers based on this evaluation, as required by 21 CFR 1.505(b) for your Mini Patisseries from your foreign supplier (b)(4) and (b)(4) from your foreign supplier (b)(4) located in (b)(4). Under 21 CFR 1.505(a), you must consider the hazard analysis of the food, the entity or entities that would be significantly minimizing or preventing the hazards requiring a control or verifying that such hazards have been significantly minimized or prevented, the foreign supplier performance, and any other factors as appropriate and necessary. During our inspection, you provided several records that you said you obtained from your distributor, (b)(4), located in (b)(4). The records for your Mini Patisseries from (b)(4), included a (b)(3)(A), a one-page Safety Food Certificate that declared compliance with “Reg. CE 852/04 (Food hygiene)” (which appears to be a European Union standard) dated 2024-04-02; and a data sheet for Mini Pastries from (b)(4) dated 02/10/2024. The records for your (b)(4), included third party audit certificates dated (b)(4); customer letter dated 30/01/2025; egg pasteurization declaration dated 26/09/2024; manufacturer’s declaration dated 02/10/2024; heat treatment for egg products dated 6 Giugno 2024; and a (b)(3)(A). However, you did not document your review and assessment of these records, or an evaluation of your foreign suppliers’ performance and the risk posed by a food conducted under 21 CFR 1.505(a), as required by 21 CFR 1.505(b).
Your response dated February 28, 2025, stated that FSVP procedures have been established to include conducting an evaluation or reviewing evaluations conducted by third parties to determine your foreign supplier’s performance and risk posed by a food. You also stated that you will not be importing from (b)(4) in the future, and you were advised that this company will no longer be in business. To the extent these statements are considered to represent that you reevaluated your supplier (b)(4), you must document your evaluation including that you determined it is no longer appropriate to continue to import the food from your supplier, per 21 CFR 1.505(c)(1).
Your response further added that (b)(4) has been audited by (b)(4) and the audit reports were reviewed by your consultant, (b)(6), (b)(7)(C), and found to be in compliance with food standards. However, neither the audits represented by the certificates provided during our inspection nor your consultant’s review considered the relevant food safety regulation for your (b)(4), which are the preventive controls requirements under 21 CFR part 117. In your evaluation, you did not consider your foreign supplier’s performance according to the applicable foods safety regulation, the preventive controls requirements under 21 CFR part 117, as required by 21 CFR 1.505(a)(1)(iii)(B).
2. You did not meet the requirement to perform foreign supplier verification activities as required by 21 CFR 1.506. Specifically, before importing a food from a foreign supplier you did not document your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d). With respect to the requirements of 21 CFR 1.506(e), regarding the performance of foreign supplier verification activities before importing a food from a foreign supplier, while you may rely on third-party food safety audits as part of your foreign supplier verification activities, you must ensure the audit is performed by a qualified auditor. Additionally, for food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider applicable FDA food safety regulations (or, when applicable, an onsite audit may consider relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States), in accordance with 21 CFR 1.506(e)(1)(i)(B). You must also promptly review and assess the results of any third-party audit that constitutes a verification activity, as well as document your review and assessment, among other requirements (21 CFR 1.506(e)(3)).
Specifically, you did not document your determination or performance of appropriate supplier verification activities before importing Mini Patisseries from your foreign supplier (b)(4), or (b)(4) from your foreign supplier (b)(4), as required by 21 CFR 1.506(d) and 21 CFR 1.506(e). Although your response included written procedures titled, “Evaluation and Approval of Foreign Suppliers FSVP,” you did not provide documentation of your determination of the appropriate supplier verification activity or activities, or the frequency with which the activity or activities must be conducted, as required by 21 CFR 1.506(d).
Further, while you obtained several documents as described above, including a Safety Food Certificate dated 2024-04-02 and data sheet for (b)(4) dated 02/10/2024, and third-party audit certificates dated 27 March 2024 and 2024-03-28 for (b)(4), these records do not indicate that applicable FDA food safety regulations were considered (preventive controls requirements under 21 CFR part 117). Further, during our inspection and before importing the food from your foreign suppliers, you did not promptly review and assess any third-party audit that constitutes a verification activity, or document your review and assessment (21 CFR 1.506(e)(3)).
We acknowledge that your response dated February 28, 2025 stated you would stop importing from (b)(4), and your consultant described a review and assessment of the audit reports described above for (b)(4). We will continue to assess the adequacy of your corrective actions in our next inspection.
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 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 the foods you import for which you appear to be in violation of section 805 of the FD&C Act. We may place the foods 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 #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 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: Coral del Mar Lopez, Compliance Officer, Division of Southeast Imports, 959 Ridgeway Loop Rd. Suite #100, Memphis, TN 38120. If you have any questions regarding this letter, you may contact Officer Lopez via email at coraldelmar.lopez@fda.hhs.gov. Please reference CMS No. 705728 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/
Sherea Dillon
Acting Program Division Director
Division of Southeast Imports
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