As part of its enforcement efforts, the Food and Drug Administration sends warning letters to companies for which it is responsible. Some letters are only made publicly available weeks or months after they have been sent. Business owners have 15 days to respond to FDA warning letters. Warning letters are often not issued until a company has been given months to years to correct problems. The FDA often edits portions of warning letters that are published for public viewing.

Italfoods Inc.
San Francisco, CA.

An import company in California is informed by the FDA that there are no FSVPs for a number of imported foods.

In a warning letter dated Oct. 27, the FDA described a Foreign Supplier Verification Program (FSVP) inspection from June 15 to July 8 at Italfoods Inc. The FDA’s inspection found the company to be in breach of FSVP regulations and was conducting to issue an FDA Form 483a. The main violations are as follows:

The company has not developed, maintained, or followed an FSVP. Specifically:

  1. The company did not meet the requirements to carry out a hazard analysis for the cheese products Pecorino Toscano DOP Stagionato, Pecorino Cacio Di Bosco Tartufo Stagio and Pecorino Brillo Formaggio imported from foreign suppliers (edited). Although they emailed the FDA a copy of the hazard analysis carried out by their overseas supplier, they told the FDA investigator that their company had not reviewed or assessed it. Because the company relies on the overseas supplier’s hazard analysis to meet its obligations under the FSVP regulation, it has not provided the FDA with evidence that it has documented its overseas supplier’s hazard assessment review and assessment. The company can meet its requirement to conduct a hazard analysis by documenting the review and assessment of the hazard analysis of its foreign supplier, including documentation that the hazard analysis was performed by a qualified person.

On August 5, company officials responded to this violation on FDA Form 483a stating that they will “review the required hazard analysis by the overseas supplier and list the potential risks and, if necessary, document our assessment.” The FDA was unable to assess the appropriateness of their response as it has not yet submitted any documentation showing that they have completed their overseas supplier’s hazard analysis review and assessment, including documentation that the hazard analysis was carried out by a qualified person.

  1. The company’s FSVP is inadequate due to deficiencies in the approval process for foreign suppliers and supplier screening activities. They must correspond to the assessment for approval and verification activities of foreign suppliers. Although they provided the FDA with a questionnaire checklist titled “Italfoods Food Safety Modernization Act (FSMA) Vendor Compliance,” which they send to their overseas suppliers, this form does not meet their FSVP requirements. In particular, the company must approve its foreign suppliers based on an assessment of the performance of the foreign supplier and the risk posed by the food and document their approval. The company has not demonstrated that it considered applicable FDA food safety regulations or compliance by its overseas supplier in its assessment, nor does it have a basis for approval of its overseas supplier based on its assessment of the performance of its overseas supplier Suppliers documented.

In the company’s response on August 5, 2020, Form 483a, they stated that they “had written review activities in place. . . . “However, the FDA is unable to assess the appropriateness of its response as it has not submitted copies of these documents containing these written review activities.

  1. The company has not established and followed any written procedures to ensure that food is only imported from foreign suppliers who have approved it. They have not documented their use of these procedures. During the inspection, they presented the FDA with a one-page document titled “Italfoods FSVP Process”. The company’s FSVP procedures contained only general bullet points such as “GMPs” and “Recall Program” that were not product or supplier specific and did not provide any further details. They did not indicate whether or how they will ensure that they only import food from overseas suppliers who have approved them, based on an assessment of the overseas supplier’s performance and the risk posed by the food.

In their August 5 response, Form 483a, they stated that their “policy is only to buy and import food products from suppliers who meet the requirements and are approved by the FDA’s FSVP team.” The FDA has not been able to assess the appropriateness of its response as it has not yet submitted any documents specifying written procedures to assess and approve the performance of its overseas supplier, nor has it submitted any written documents to show it how they followed these procedures.

  1. The company has not established and followed adequate written procedures to ensure that appropriate screening activities are being carried out for overseas suppliers on the food they are importing. Their August 5, 2020 483a response indicates that they have put in place written review activities to ensure that the hazards to food imported from their overseas supplier are minimized and prevented. However, the FDA is unable to assess the appropriateness of their response as it has not provided the actual written procedures established for their overseas supplier. (edited)Pecorino Toscano DOP Stagionato Cheese, Pecorino Cacio Di Bosco Tartufo Stagio Cheese and Pecorino Brillo Formaggio Cheese especially for their imported foods.
  2. The company did not meet the requirement to immediately reassess the performance of its overseas supplier and the risk associated with a food and to document the concerns associated with these risks when it became aware of new information about these risk factors. Specifically on May 28th this year when they became aware of the positive FDA lab Listeria monocytogenes As a result for their Pecorino Toscana DOP Stagionato cheese, they did not promptly reassess concerns about the performance of their overseas supplier and the risk associated with the cheese. If the company determines that the concerns associated with importing a food from a foreign supplier have changed, it must immediately determine (and document) whether it is appropriate to continue to import the food from a foreign supplier and whether the activities Required for supplier verification are changed.

The company informed the FDA investigator that they had positively informed their overseas supplier about the FDA laboratory Listeria monocytogenes Result on May 28th. They also stated that their overseas supplier had given them corrective actions and assurances that they would try (edited) They export to the USA (including sampling for Listeria monocytogenes) and provide their US customers with a Certificate of Analysis (COA).

During the closing meeting on July 28, company officials said they had not reassessed their overseas supplier’s performance and risks from the cheese. In their August 5 response to the 483a, more than two months after they became aware of the concern, they stated they will not make any new purchases until they reevaluate the supplier and have lab testing on the reordered shipments as part of theirs Suppliers have carried out re-evaluation. The FDA is unable to assess the appropriateness of its response as it has not provided documentation of its re-evaluation or written determination as to whether it is appropriate to continue to import the food from the overseas supplier and whether its supplier review activities need to be changed. When you have fully corrected these violations, you can include documentation about them in your response to this letter.

  1. The company has failed to take adequate corrective action after the results of a verification activity failed to sufficiently ensure that a hazard requiring inspection of the food received from its overseas supplier was significantly minimized or prevented. Especially during her (edited) Review and evaluation of the food safety plan of their foreign supplier and (edited) They did not find that the audit report did not cover their supplier’s environmental monitoring program. The Company has not taken corrective action as a result if a foreign supplier of the food it imports fails to manufacture the food in accordance with processes and procedures that provide at least the same level of public health protection as those set out in Section 418 of the FD & C-Law (hazard) analysis and risk-based preventive controls required) and current good manufacturing practice, hazard analysis and risk-based preventive controls for the implementation of human regulations in 21 CFR Part 117 Subsection C. The company must document all corrective actions taken by it.

In the company’s 483a response, they stated that they “worked with the supplier to obtain documents for corrective action, etc.” However, the FDA was unable to assess the appropriateness of their response as it failed to provide these documents to the FDA. They went on to state that they “understand that we need to document all actions taken in our reassessment process,” but they have not provided the FDA with written documentation of all actions they have taken (e.g., a recently published review report that the environmental monitoring program of a foreign supplier and its documented review and evaluation of this report contain a review of their measures).

The full warning letter can be viewed Here.

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