As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.
Italfoods Inc.
San Francisco, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 27 warning letter, the FDA described a June 15-July 8 Foreign Supplier Verification Program (FSVP) inspection at Italfoods Inc. The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in the issuance of an FDA Form 483a. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically:
- The firm did not meet their requirements to conduct a hazard analysis for their Pecorino Toscano DOP Stagionato, Pecorino Cacio Di Bosco Tartufo Stagio, and Pecorino Brillo Formaggio cheese products imported from foreign supplier (redacted). Although they emailed the FDA a copy of the hazard analysis conducted by their foreign supplier, they stated to the FDA investigator that their firm had not reviewed or assessed it. As the firm relies on the foreign supplier’s hazard analysis to meet their obligations under the FSVP regulation, they did not provide FDA with any evidence that they documented their review and assessment of their foreign supplier’s hazard analysis. The firm may meet their requirement to conduct a hazard analysis, by documenting their review and assessment of their foreign supplier’s hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual.
On Aug. 5, the firm officials responded to this violation on the FDA Form 483a by stating that they “will review the required hazard analysis by the foreign supplier listing the potential risks and document our evaluation when necessary.” The FDA was unable to evaluate the adequacy of their response because they still have not provided any documentation showing that they have completed their review and assessment of their foreign supplier’s hazard analysis, including providing documentation that the hazard analysis was conducted by a qualified individual.
- The firm’s FSVP is inadequate due to deficiencies in their foreign supplier approval process and supplier verification activities. They must comply with the evaluation for foreign supplier approval and verification activities. Although they provided FDA with a questionnaire checklist titled “Italfoods Food Safety Modernization Act (FSMA) Vendor Compliance” that they send to their foreign suppliers, this form does not fulfill their FSVP requirements. Specifically, the firm must approve their foreign suppliers based on an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. The firm did not demonstrate that they considered applicable FDA food safety regulations or their foreign supplier’s compliance with such in their evaluation, nor did they document any basis for approving their foreign supplier based on their evaluation of their foreign supplier’s performance.
In the firm’s August 5, 2020 Form 483a response, they stated that they “have established written verification activities . . . .” However, the FDA is unable to evaluate the adequacy of their response because they have not provided copies of those documents containing those written verification activities.
- The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved. They did not document their use of these procedures. Specifically, during the inspection, they presented FDA with a one‐page document titled “Italfoods FSVP procedures.” The firm’s 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. They did not indicate whether or how they will ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food.
In their Aug. 5 Form 483a response, they stated that their “policy is only to purchase and import food products from those suppliers who are in compliance and approved by the FDA FSVP team.” The FDA was unable to evaluate the adequacy of their response because they still have not provided any documentation establishing written procedures for evaluating and approving their foreign supplier’s performance, nor have they provided written documentation showing how they have followed those procedures.
- The firm did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the food they import. Their 483a response dated August 5, 2020 indicates that they have established written verification activities ensuring that hazards for food imported from their foreign supplier are minimized and prevented. However, the FDA is unable to evaluate the adequacy of their response because they did not provide the actual established written procedures for their foreign supplier, (redacted), nor specifically for their imported food items Pecorino Toscano DOP Stagionato cheese, Pecorino Cacio Di Bosco Tartufo Stagio cheese, and Pecorino Brillo Formaggio cheese.
- The firm did not meet the requirement to promptly reevaluate their foreign supplier’s performance and the risk posed by a food, and document the concerns associated with those risks, when they became aware of new information about those risk factors. Specifically, on May 28 this year when they became aware of the FDA laboratory positive Listeria monocytogenes result for their Pecorino Toscana DOP Stagionato Cheese, they did not promptly reevaluate the concerns associated with their foreign supplier’s performance and the risk posed by the cheese. If the firm determines that the concerns associated with importing a food from a foreign supplier have changed, they 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 need to be changed.
The firm told the FDA investigator that they informed their foreign supplier of the FDA laboratory positive Listeria monocytogenes result on May 28. They further stated that their foreign supplier provided them with corrective actions and assurances that they will sample (redacted) they export to the USA (including sampling for Listeria monocytogenes) and will provide their U.S. customers with a certificate of analysis (COA).
During the closeout meeting on July 28, the firm officials said they had not reevaluated their foreign supplier’s performance and risks posed by the cheese. In their Aug. 5 response to the 483a, more than two months after they became aware of the concern, they stated they will not issue new purchases until they have reevaluated the supplier and conducted lab testing for the back ordered shipments as part of their supplier reassessment. The FDA is unable to evaluate the adequacy of their response because they did not provide documentation of their reevaluation or written determination of whether it is appropriate to continue to import the food from the foreign supplier and whether their supplier verification activities need to be changed. If they have fully corrected these violations, they may submit documentation of such in their response to this letter.
- The firm did not take appropriate corrective action after the results of a verification activity did not provide adequate assurances that a hazard requiring a control in the food they obtain from their foreign supplier has been significantly minimized or prevented. Specifically, during their (redacted) review and assessment of their foreign supplier’s food safety plan and (redacted) third‐party audit report, they failed to note that the audit report did not cover their supplier’s environmental monitoring program. The firm then failed to take corrective action when a foreign supplier of food they 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. The firm is required to document any corrective actions they take.
In the firm’s 483a response, they stated that they “worked with the supplier to obtain corrective action documents, etc.” However, the FDA was unable to evaluate the adequacy of their response because they failed to provide these documents to FDA. They further stated that they “understand we need to document all actions taken in our re‐evaluation process” but they have failed to provide FDA with written documentation of any action they have taken (such as a recent audit report that includes a review of their foreign supplier’s environmental monitoring program and their documented review and assessment of that report).
