WARNING LETTER
Cantoro Food Market
MARCS-CMS 635063 —
July 21, 2022
Delivery Method:
Via Express Delivery
Product:
Food & Beverages
Recipient:
Recipient Name
Michael A. Fallone
Cantoro Food Market
15550 N Haggerty Rd.
Plymouth
,
MI
48170-4892
United States
Issuing Office:
Division of Northern Border Imports
United States
July 21, 2022
WARNING LETTER
Re: CMS #635063
Dear Michael A. Fallone:
On May 12 to 21, 2022, the Food and Drug Administration (FDA) conducted a Foreign Supplier Verification Program (FSVP) inspection of your firm Cantoro Food Market located at 15550 N. Haggerty Rd., Plymouth, MI 48170. We also conducted an inspection on November 4, 2019. 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 most recent 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 most recent inspection, our investigator provided you with a Form FDA 483a FSVP Observations. We acknowledge receipt of your response on June 09, 2022, which included the following documents: an audit food safety certificate from
(b)(4)
issued September 07, 2021, for foreign supplier
(b)(4)
for tomato products; an audit certificate from
(b)(4)
issued July 30, 2021, for foreign supplier
(b)(4)
, for dried apricots, dried figs and sun-dried tomatoes; and a Food Safety Plan for Durum Wheat Pasta from foreign supplier
(b)(4)
dated October 25, 2021. You did not provide an explanation of these documents, describe how they would apply to your FSVP program, or provide a record of your review of these documents. We address your response below.
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, except for the following foods:
Tomato Paste imported from
(b)(4)
Dried Turkish figs imported from
(b)(4)
Spaghetti Pasta imported from
(b)(4)
While you provided FSVP documents for the tomato paste you import from
(b)(4)
, the dried Turkish figs you import from
(b)(4)
, and the spaghetti pasta you import from
(b)(4)
, these documents do not meet the FSVP requirements, as discussed below.
2. You did not meet the requirement to conduct a written hazard analysis for each type of food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504. Although you may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, you must document your review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual (21 CFR 1.504(d)). While you have obtained the hazard analysis from your foreign supplier for your spaghetti pasta imported from
(b)(4)
, you did not document your review and assessment of that hazard analysis or that the hazard analysis was conducted by a qualified individual, as required under 21 CFR 1.504(d). For your tomato paste you import from
(b)(4)
and your dried Turkish figs you import from
(b)(4)
, you did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for the food you import to determine whether there are any hazards requiring a control, as required by 21 CFR 1.504.
3. 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). Specifically, for your spaghetti pasta you import from
(b)(4)
, your tomato paste you import from
(b)(4)
, and your dried Turkish figs you import from
(b)(4)
, you did not provide documentation that you have evaluated your foreign supplier’s performance and risk posed by the food, as required by 21 CFR 1.505(a), or your approval of these suppliers, as required by 21 CFR 1.505(b).
4. You did not meet the requirements to perform foreign supplier verification activities in accordance with 21 CFR 1.506. Specifically, for your spaghetti pasta you import from
(b)(4)
, your tomato paste you import from
(b)(4)
, and your dried Turkish figs you import from
(b)(4)
, you did not determine and document which verification activity or activities, as well as the frequency with which the activity or activities must be conducted, are needed to provide adequate assurances that the food you obtain from the foreign supplier is produced in accordance with 21 CFR 1.506(c), as required by 21 CFR 1.506(d). In addition, you did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each of these foreign suppliers before importing these foods and periodically thereafter, as required by 21 CFR 1.506(e).
With respect to the requirements of 21 CFR 1.506(e), while you may rely on supplier verification activities conducted in accordance with 21 CFR 1.506(e)(1) by another entity, you must promptly review and assess the results of the verification activities conducted by another entity and document your review and assessment (21 CFR 1.506(e)(3)). In addition, for an onsite audit, you must retain documentation of each onsite audit, including the audit procedures, the dates the audit was conducted, the conclusions of the audit, any corrective actions taken in response to significant deficiencies identified during the audit, and documentation that the audit was conducted by a qualified auditor (21 CFR 1.506(e)(1)(i)(D)). For food that is subject to one or more FDA food safety regulations, an onsite audit of the foreign supplier must consider such regulations and include a review of the supplier’s written food safety plan, if any, and its implementation, for the hazard being controlled (21 CFR 1.506(e)(1)(i)(B)). The third-party audit certificates for your foreign suppliers
(b)(4)
and
(b)(4)
do not include audit procedures; they also do not indicate that they assessed compliance with FDA food safety regulations, reviewed the supplier’s written food safety plan, or were conducted by a qualified auditor. Further, you did not provide any documentation showing that you reviewed and assessed the results of these audits. For your spaghetti pasta you import from
(b)(4)
, you did not provide any documentation that you have conducted and documented (or obtained documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv).
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)).
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 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: Julie Scoma, Compliance Officer, Division of Northern Border Imports, at Julie.Scoma@fda.hhs.gov. If you have any questions regarding this letter, you may contact CO Scoma via email. Please reference CMS #635063 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/
Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports
Content current as of:
08/16/2022
Regulated Product(s)
Food & Beverages