- Italfoods, Inc., of South San Francisco, CA did not have it in place for cheese products improted from Italy including Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese. One of the products had been found to have Listeria monocytogenes contamination.
- Handylee USA Corp. of Maspeth, NY did not have FVSP for imported canned corn. canned mushrooms and canned bamboo.
Italfoods, Inc.
MARCS-CMS 610183 — October 27, 2020
Recipient:
Georgette A. Guerra
Owner/President
Italfoods, Inc.
205 Shaw Road
South San Francisco, CA 94080
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
October 27, 2020
Re: CMS # 610183
Dear Ms. Guerra:
From June 15 through July 8, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Italfoods, Inc., located at 205 Shaw Road, South San Francisco, CA 94080. We also conducted an inspection on July 19, 2018. 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 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import, including, but not limited to, your Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese, all imported from your foreign supplier (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the initial inspection in 2018 and the follow‐up inspection in 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
This inspection was initiated based on isolation of Listeria monocytogenes from a sample of Pecorino Toscano DOP Stagionato Cheese manufactured by (b)(4) and collected from entry (b)(4) imported by your company. (b)(4) and its Pecorino Toscano Cheese were (b)(4) Due to Microbiological Contamination” based on a reported finding of Listeria monocytogenes.
We acknowledge receipt of your email responses sent July 23, 2020 and August 5, 2020. Your July 23, 2020 email requested an extension to accurately respond to Form FDA 483a, FSVP Observations issued on July 8, 2020. On August 5, 2020, your firm sent a document entitled “FDA Inspection Report” addressing the ten observations noted on the FDA 483a. We are unable to evaluate the adequacy of your response because our review of your response finds that you have not addressed all the violations related to the food products you import, as further described below:
Your significant violations of the FSVP regulation are as follows:
1. You did not meet your requirements to conduct a hazard analysis for your Pecorino Toscano DOP Stagionato, Pecorino Cacio Di Bosco Tartufo Stagio, and Pecorino Brillo Formaggio cheese products imported from your foreign supplier (b)(4), in accordance with 21 CFR 1.504. Although you emailed the FDA a copy of the hazard analysis conducted by your foreign supplier, you stated to the FDA investigator that your firm had not reviewed or assessed it. As you rely on the foreign supplier’s hazard analysis to meet your obligations under the FSVP regulation, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazard 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 documenting your review and assessment of your foreign supplier’s hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual.
On August 5, 2020, you responded to this violation on the FDA Form 483a by stating that your firm “will review the required hazard analysis by the foreign supplier listing the potential risks and document our evaluation when necessary.” We are unable to evaluate the adequacy of your response because you still have not provided any documentation showing that you have completed your review and assessment of your foreign supplier’s hazard analysis, including providing documentation that the hazard analysis was conducted by a qualified individual.
2. Your FSVP is inadequate due to deficiencies in your foreign supplier approval process and supplier verification activities. You must comply with the evaluation for foreign supplier approval and verification activities set forth in 21 CFR 1.505. Although you provided FDA with a questionnaire checklist titled “Italfoods Food Safety Modernization Act (FSMA) Vendor Compliance” that you send to your foreign suppliers, this form does not fulfill your FSVP requirements. Specifically, you must approve your foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a)(2) and document your approval, as required by 21 CFR 1.505(b). You did not demonstrate that you considered applicable FDA food safety regulations or your foreign supplier’s compliance with such in your evaluation, nor did you document any basis for approving your foreign supplier based on your evaluation of your foreign supplier’s performance as required by 21 CFR 1.505(b).
In your August 5, 2020 Form 483a response, you stated that you “have established written verification activities . . . .” However, we are unable to evaluate the adequacy of your response because you still have not provided copies of those documents containing those written verification activities.
3. In accordance with 21 CFR 1.506, you did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under §1.505. You did not document your use of these procedures as required by 1.506(a)(1). Specifically, during the inspection, you presented FDA with a one‐page document titled “Italfoods FSVP procedures.” Your FSVP procedures contained only general bulleted items such as “GMP’s” and “Recall Program” that were not product or supplier specific and did not contain any further details. You did not indicate whether or how you will ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food as required by 21 CFR 1.506(a)(1).
In your August 5, 2020 Form 483a response, you stated that your “policy is only to purchase and import food products from those suppliers who are in compliance and approved by our FSVP team.” We are unable to evaluate the adequacy of your response because you still have not provided any documentation establishing written procedures for evaluating and approving your foreign supplier’s performance, nor have you provided written documentation showing how you have followed those procedures.
4. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the food you import as required by 21 CFR 1.506(b). Your 483a response dated August 5, 2020 indicates that you have established written verification activities assuring that hazards for food imported from your foreign supplier are minimized and prevented. However, we are unable to evaluate the adequacy of your response because you did not provide the actual established written procedures for your foreign supplier, (b)(4), nor specifically for your imported food items Pecorino Toscano DOP Stagionato cheese, Pecorino Cacio Di Bosco Tartufo Stagio cheese, and Pecorino Brillo Formaggio cheese.
5. 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 May 28, 2020, when you became aware of the FDA laboratory positive Listeria monocytogenes result for your Pecorino Toscana DOP Stagionato Cheese, you did not promptly reevaluate the concerns associated with your foreign supplier’s performance and the risk posed by the cheese. 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 or §1.511(c) need to be changed.
You told the FDA investigator that you informed your foreign supplier of the FDA laboratory positive Listeria monocytogenes result on May 28, 2020. You further stated that your foreign supplier provided you with corrective actions and assurances that they will sample (b)(4) they export to the USA (including sampling for Listeria monocytogenes) and will provide their US customers with a certificate of analysis (COA).
During the closeout meeting on July 28, 2020, you said you had not reevaluated your foreign supplier’s performance and risks posed by the cheese. In your August 5, 2020 response to the 483a, more than two months after you became aware of the concern, you stated you will not issue new purchases until you have reevaluated the supplier and conducted lab testing for the back ordered shipments as part of your supplier reassessment. We are unable to evaluate the adequacy of your response because you did not provide documentation of your reevaluation or written determination of whether it is appropriate to continue to import the food from the foreign supplier and whether your supplier verification activities need to be changed required by 21 CFR 1.505(c)(1). If you have fully corrected these violations, you may submit documentation of such in your response to this letter.
6. You did not take appropriate corrective action in accordance with 21 CFR 1.508(a) after the results of a verification activity did not provide adequate assurances that a hazard requiring a control in the food you obtain from your foreign supplier has been significantly minimized or prevented, as required by 21 CFR 1.506(e)(3). Specifically, during your (b)(4) review and assessment of your foreign supplier’s food safety plan and (b)(4) third‐party audit report, you failed to note that the audit report did not cover your supplier’s environmental monitoring program. You then failed to take corrective action as required under 21 CFR 1.506(a) when a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the FD&C Act (Hazard Analysis and Risk‐Based Preventative Controls) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk‐Based Preventative Controls for Human Food implementing regulation in 21 CFR part 117 subpart C. You are required to document any corrective actions you take in accordance with 21 CFR 1.508(a).
In your 483a response, you stated that you “worked with the supplier to obtain corrective action documents, etc.” However, we are unable to evaluate the adequacy of your response because you failed to provide these documents to FDA. You further stated that you “understand we need to document all actions taken in our re‐evaluation process” but you have failed to provide FDA with written documentation of any action you have taken (such as a recent audit report that includes a review of your foreign supplier’s environmental monitoring program and your documented review and assessment of that report).
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 the Pecorino Toscano DOP Stagionato, Pecorino Cacio Di Bosco Tartufo Stagio, and Pecorino Brillo Formaggio, all imported from your foreign supplier, (b)(4). We may place these foods 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 Act or 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: William J Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS #610183 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
Importer’s contact information:
Georgette A. Guerra, Owner President
205 Shaw Road
South San Francisco, CA 94080
Gguerra@italfoodsinc.com
Cc: richarda@italfoodsinc.com
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/handylee-usa-corp-609844-10222020
Handylee USA Corp.
MARCS-CMS 609844 — October 22, 2020
Recipient:
Mr. Benjamin Lee/Mr. Simon Lee
Owners
Handylee USA Corp.
5530 58th St
Maspeth, NY 11378
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 609844
October 22, 2020
Dear Mr. Benjamin Lee & Mr. Simon Lee:
From June 18 through July 7, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Handylee USA Corp. located at 5530 58th St. Maspeth, NY 11378. We also conducted an initial FSVP inspection on August 7, 2017. 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 Foreign Supplier Verification Program (FSVP) implementing 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.
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 food products you import including, but not limited to, canned corn imported from your foreign supplier (b)(4); canned mushrooms imported from your foreign supplier (b)(4); and canned bamboo imported from your foreign supplier (b)(4). Your firm did not have FSVPs for these products, or any of the other products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on August 7, 2017, and the follow-up inspection on July 7, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
To this date, we have not received your response to Form FDA 483a, which was issued on July 7, 2020.
Your significant violations of the FSVP regulation are as follows:
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, your firm did not develop an FSVP for each of the following foods:
• Canned corn imported from (b)(4)
• Canned mushrooms imported from (b)(4)
• Canned bamboo imported from (b)(4)
In addition, for thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods) and with respect to the microbiological hazards associated with these food products, you must verify and document that they were produced in accordance with 21 CFR part 113. Specifically, you did not verify and document that the food products listed above were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).
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 the food products you import. We may place the foods you import 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.
In addition to the above violations, we also have the following comments:
In order to comply with the FSVP regulation, you must also conduct a hazard analysis for the products you import in accordance with 21 CFR 1.504. A hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards (including pesticide residues), and physical hazards (21 CFR 1.504(b)(1)). We note that straw mushrooms from (b)(4) and (b)(4) are currently subject to DWPE as they appear to be adulterated and contain a chemical pesticide that is unsafe with the meaning of section 408(a). You import straw mushrooms from (b)(4) and you import golden and oyster mushrooms from (b)(4). Applicable FDA food safety regulations and information relevant to your foreign supplier’s compliance with those regulations, including but not limited to whether or not your foreign supplier is subject to an import alert is an important aspect of evaluating your foreign supplier’s performance (21 CFR 1.505). Furthermore, understanding the known or reasonably foreseeable hazards, such as pesticides, in the foods you import should be considered when determining the appropriate foreign supplier verification activities (21 CFR 1.506).
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 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 send your reply to Food and Drug Administration, Attention: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 609844 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
Georgette A. Guerra
Owner/President
Italfoods, Inc.
205 Shaw Road
South San Francisco, CA 94080
United States
Issuing Office:
Division of West Coast Imports
United States
WARNING LETTER
October 27, 2020
Re: CMS # 610183
Dear Ms. Guerra:
From June 15 through July 8, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Italfoods, Inc., located at 205 Shaw Road, South San Francisco, CA 94080. We also conducted an inspection on July 19, 2018. 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 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 our most recent inspection, we found that you are not in compliance with the requirements of 21 CFR part 1 subpart L for the food products you import, including, but not limited to, your Pecorino Toscano DOP Stagionato cheese, your Pecorino Cacio Di Bosco Tartufo Stagio cheese, and your Pecorino Brillo Formaggio cheese, all imported from your foreign supplier (b)(4). Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of the initial inspection in 2018 and the follow‐up inspection in 2020, our investigator provided you in each instance with a Form FDA 483a, FSVP Observations.
This inspection was initiated based on isolation of Listeria monocytogenes from a sample of Pecorino Toscano DOP Stagionato Cheese manufactured by (b)(4) and collected from entry (b)(4) imported by your company. (b)(4) and its Pecorino Toscano Cheese were (b)(4) Due to Microbiological Contamination” based on a reported finding of Listeria monocytogenes.
We acknowledge receipt of your email responses sent July 23, 2020 and August 5, 2020. Your July 23, 2020 email requested an extension to accurately respond to Form FDA 483a, FSVP Observations issued on July 8, 2020. On August 5, 2020, your firm sent a document entitled “FDA Inspection Report” addressing the ten observations noted on the FDA 483a. We are unable to evaluate the adequacy of your response because our review of your response finds that you have not addressed all the violations related to the food products you import, as further described below:
Your significant violations of the FSVP regulation are as follows:
1. You did not meet your requirements to conduct a hazard analysis for your Pecorino Toscano DOP Stagionato, Pecorino Cacio Di Bosco Tartufo Stagio, and Pecorino Brillo Formaggio cheese products imported from your foreign supplier (b)(4), in accordance with 21 CFR 1.504. Although you emailed the FDA a copy of the hazard analysis conducted by your foreign supplier, you stated to the FDA investigator that your firm had not reviewed or assessed it. As you rely on the foreign supplier’s hazard analysis to meet your obligations under the FSVP regulation, you did not provide FDA with any evidence that you documented your review and assessment of your foreign supplier’s hazard 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 documenting your review and assessment of your foreign supplier’s hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual.
On August 5, 2020, you responded to this violation on the FDA Form 483a by stating that your firm “will review the required hazard analysis by the foreign supplier listing the potential risks and document our evaluation when necessary.” We are unable to evaluate the adequacy of your response because you still have not provided any documentation showing that you have completed your review and assessment of your foreign supplier’s hazard analysis, including providing documentation that the hazard analysis was conducted by a qualified individual.
2. Your FSVP is inadequate due to deficiencies in your foreign supplier approval process and supplier verification activities. You must comply with the evaluation for foreign supplier approval and verification activities set forth in 21 CFR 1.505. Although you provided FDA with a questionnaire checklist titled “Italfoods Food Safety Modernization Act (FSMA) Vendor Compliance” that you send to your foreign suppliers, this form does not fulfill your FSVP requirements. Specifically, you must approve your foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a)(2) and document your approval, as required by 21 CFR 1.505(b). You did not demonstrate that you considered applicable FDA food safety regulations or your foreign supplier’s compliance with such in your evaluation, nor did you document any basis for approving your foreign supplier based on your evaluation of your foreign supplier’s performance as required by 21 CFR 1.505(b).
In your August 5, 2020 Form 483a response, you stated that you “have established written verification activities . . . .” However, we are unable to evaluate the adequacy of your response because you still have not provided copies of those documents containing those written verification activities.
3. In accordance with 21 CFR 1.506, you did not establish and follow written procedures to ensure that you import foods only from foreign suppliers you have approved based on the evaluation conducted under §1.505. You did not document your use of these procedures as required by 1.506(a)(1). Specifically, during the inspection, you presented FDA with a one‐page document titled “Italfoods FSVP procedures.” Your FSVP procedures contained only general bulleted items such as “GMP’s” and “Recall Program” that were not product or supplier specific and did not contain any further details. You did not indicate whether or how you will ensure that you import foods only from foreign suppliers you have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food as required by 21 CFR 1.506(a)(1).
In your August 5, 2020 Form 483a response, you stated that your “policy is only to purchase and import food products from those suppliers who are in compliance and approved by our FSVP team.” We are unable to evaluate the adequacy of your response because you still have not provided any documentation establishing written procedures for evaluating and approving your foreign supplier’s performance, nor have you provided written documentation showing how you have followed those procedures.
4. You did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the food you import as required by 21 CFR 1.506(b). Your 483a response dated August 5, 2020 indicates that you have established written verification activities assuring that hazards for food imported from your foreign supplier are minimized and prevented. However, we are unable to evaluate the adequacy of your response because you did not provide the actual established written procedures for your foreign supplier, (b)(4), nor specifically for your imported food items Pecorino Toscano DOP Stagionato cheese, Pecorino Cacio Di Bosco Tartufo Stagio cheese, and Pecorino Brillo Formaggio cheese.
5. 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 May 28, 2020, when you became aware of the FDA laboratory positive Listeria monocytogenes result for your Pecorino Toscana DOP Stagionato Cheese, you did not promptly reevaluate the concerns associated with your foreign supplier’s performance and the risk posed by the cheese. 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 or §1.511(c) need to be changed.
You told the FDA investigator that you informed your foreign supplier of the FDA laboratory positive Listeria monocytogenes result on May 28, 2020. You further stated that your foreign supplier provided you with corrective actions and assurances that they will sample (b)(4) they export to the USA (including sampling for Listeria monocytogenes) and will provide their US customers with a certificate of analysis (COA).
During the closeout meeting on July 28, 2020, you said you had not reevaluated your foreign supplier’s performance and risks posed by the cheese. In your August 5, 2020 response to the 483a, more than two months after you became aware of the concern, you stated you will not issue new purchases until you have reevaluated the supplier and conducted lab testing for the back ordered shipments as part of your supplier reassessment. We are unable to evaluate the adequacy of your response because you did not provide documentation of your reevaluation or written determination of whether it is appropriate to continue to import the food from the foreign supplier and whether your supplier verification activities need to be changed required by 21 CFR 1.505(c)(1). If you have fully corrected these violations, you may submit documentation of such in your response to this letter.
6. You did not take appropriate corrective action in accordance with 21 CFR 1.508(a) after the results of a verification activity did not provide adequate assurances that a hazard requiring a control in the food you obtain from your foreign supplier has been significantly minimized or prevented, as required by 21 CFR 1.506(e)(3). Specifically, during your (b)(4) review and assessment of your foreign supplier’s food safety plan and (b)(4) third‐party audit report, you failed to note that the audit report did not cover your supplier’s environmental monitoring program. You then failed to take corrective action as required under 21 CFR 1.506(a) when a foreign supplier of food you import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 of the FD&C Act (Hazard Analysis and Risk‐Based Preventative Controls) and the Current Good Manufacturing Practice, Hazard Analysis, and Risk‐Based Preventative Controls for Human Food implementing regulation in 21 CFR part 117 subpart C. You are required to document any corrective actions you take in accordance with 21 CFR 1.508(a).
In your 483a response, you stated that you “worked with the supplier to obtain corrective action documents, etc.” However, we are unable to evaluate the adequacy of your response because you failed to provide these documents to FDA. You further stated that you “understand we need to document all actions taken in our re‐evaluation process” but you have failed to provide FDA with written documentation of any action you have taken (such as a recent audit report that includes a review of your foreign supplier’s environmental monitoring program and your documented review and assessment of that report).
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 the Pecorino Toscano DOP Stagionato, Pecorino Cacio Di Bosco Tartufo Stagio, and Pecorino Brillo Formaggio, all imported from your foreign supplier, (b)(4). We may place these foods 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 Act or 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: William J Park, Compliance Officer, Division of West Coast Imports, One World Trade Center, Suite 300, Long Beach, CA 90831. If you have any questions regarding this letter, you may contact William Park via email at william.park@fda.hhs.gov. Please reference CMS #610183 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/
Dan R. Solis
Program Division Director
Division of West Coast Imports
Importer’s contact information:
Georgette A. Guerra, Owner President
205 Shaw Road
South San Francisco, CA 94080
Gguerra@italfoodsinc.com
Cc: richarda@italfoodsinc.com
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/handylee-usa-corp-609844-10222020
Handylee USA Corp.
MARCS-CMS 609844 — October 22, 2020
Recipient:
Mr. Benjamin Lee/Mr. Simon Lee
Owners
Handylee USA Corp.
5530 58th St
Maspeth, NY 11378
United States
Issuing Office:
Division of Northeast Imports
United States
WARNING LETTER
CMS # 609844
October 22, 2020
Dear Mr. Benjamin Lee & Mr. Simon Lee:
From June 18 through July 7, 2020, the Food and Drug Administration conducted a remote Foreign Supplier Verification Program (FSVP) inspection at Handylee USA Corp. located at 5530 58th St. Maspeth, NY 11378. We also conducted an initial FSVP inspection on August 7, 2017. 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 Foreign Supplier Verification Program (FSVP) implementing 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-supplierverification-programs-fsvp-importers-food-humans-and-animals.
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 food products you import including, but not limited to, canned corn imported from your foreign supplier (b)(4); canned mushrooms imported from your foreign supplier (b)(4); and canned bamboo imported from your foreign supplier (b)(4). Your firm did not have FSVPs for these products, or any of the other products that you import. Because of these significant violations, you are not in compliance with section 805 of the FD&C Act.
At the conclusion of both the initial FSVP inspection on August 7, 2017, and the follow-up inspection on July 7, 2020, our investigator provided you with Form FDA 483a, FSVP Observations.
To this date, we have not received your response to Form FDA 483a, which was issued on July 7, 2020.
Your significant violations of the FSVP regulation are as follows:
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, your firm did not develop an FSVP for each of the following foods:
• Canned corn imported from (b)(4)
• Canned mushrooms imported from (b)(4)
• Canned bamboo imported from (b)(4)
In addition, for thermally processed low-acid foods packaged in hermetically sealed containers (low-acid canned foods) and with respect to the microbiological hazards associated with these food products, you must verify and document that they were produced in accordance with 21 CFR part 113. Specifically, you did not verify and document that the food products listed above were produced in accordance with 21 CFR part 113 (regarding thermally processed low-acid foods packaged in hermetically sealed containers), as required by 21 CFR 1.502(b)(1).
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 the food products you import. We may place the foods you import 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.
In addition to the above violations, we also have the following comments:
In order to comply with the FSVP regulation, you must also conduct a hazard analysis for the products you import in accordance with 21 CFR 1.504. A hazard analysis must identify known or reasonably foreseeable hazards for each type of food you import to determine whether there are any hazards requiring a control (21 CFR 1.504(a)). The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards (including pesticide residues), and physical hazards (21 CFR 1.504(b)(1)). We note that straw mushrooms from (b)(4) and (b)(4) are currently subject to DWPE as they appear to be adulterated and contain a chemical pesticide that is unsafe with the meaning of section 408(a). You import straw mushrooms from (b)(4) and you import golden and oyster mushrooms from (b)(4). Applicable FDA food safety regulations and information relevant to your foreign supplier’s compliance with those regulations, including but not limited to whether or not your foreign supplier is subject to an import alert is an important aspect of evaluating your foreign supplier’s performance (21 CFR 1.505). Furthermore, understanding the known or reasonably foreseeable hazards, such as pesticides, in the foods you import should be considered when determining the appropriate foreign supplier verification activities (21 CFR 1.506).
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 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 send your reply to Food and Drug Administration, Attention: David A Trent-Carlson, FDA Compliance Officer; Division of Northeast Imports: ORAOEIONEIMPORTSWLResponses@fda.hhs.gov. Please also cc (carbon copy) david.trent-carlson@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Trent-Carlson via email at david.trent-carlson@fda.hhs.gov. Please reference CMS # 609844 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/
Dawne Hines
Program Division Director
Division of Northeast Imports
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