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.
EH Maldonado and Company
Rio Rico, AZ
An import company in Arizona is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 28, 2022, warning letter the FDA described an April 28, 2022, Foreign Supplier Verification Program (FSVP) inspection of EH Maldonado and Company in Rio Rico, AZ.
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 as required. Specifically, they did not develop an FSVP for any of the food products they import, including each of the following foods:
- Honeydew Melons imported from (redacted)
- Honeydew Melons imported from (redacted)
- Keitt Mangoes imported from (redacted)
The full warning letter can be viewed here.
Cantoro Food Market
Plymouth, MI
An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.
In a July 21, 2022, warning letter the FDA described a May 12-21, 2022, Foreign Supplier Verification Program (FSVP) inspection of Cantoro Food Market in Plymouth, MI.
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:
1. The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the foods they import, except for the following foods:
- Tomato Paste imported from (redacted)
- Dried Turkish figs imported from (redacted)
- Spaghetti Pasta imported from (redacted)
While the firm provided FSVP documents for the tomato paste they import from (redacted), the dried Turkish figs they import from (redacted), and the spaghetti pasta they import from (redacted), these documents do not meet the FSVP requirements, as discussed below.
2. The firm did not meet the requirement to conduct a written hazard analysis for each type of food they import to determine whether there are any hazards requiring a control, as required. Although they may meet this requirement by reviewing and assessing the hazard analysis conducted by another entity using a qualified individual, they must document their review and assessment of that hazard analysis, including documenting that the hazard analysis was conducted by a qualified individual. While they have obtained the hazard analysis from their foreign supplier for their spaghetti pasta imported from (redacted), they did not document their review and assessment of that hazard analysis or that the hazard analysis was conducted by a qualified individual, as required. For the firm’s tomato paste they import from (redacted) and their dried Turkish figs they import from (redacted), they did not provide a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards for the food they import to determine whether there are any hazards requiring a control, as required.
3. The firm did not meet the requirement to evaluate their foreign supplier’s performance and the risk posed by the food, as required. Specifically, for their spaghetti pasta they import from (redacted), their tomato paste they import from (redacted), and their dried Turkish figs they import from (redacted), they did not provide documentation that they have evaluated their foreign supplier’s performance and risk posed by the food, as required, or their approval of these suppliers, as required.
4. The firm did not meet the requirements to perform foreign supplier verification activities. Specifically, for their spaghetti pasta they import from (redacted), the tomato paste they import from (redacted), and their dried Turkish figs they import from (redacted), they 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 they obtain from the foreign supplier is produced, as required. In addition, they did not conduct and document (or obtain documentation of) one or more of the supplier verification activities for each of these foreign suppliers before importing these foods and periodically thereafter, as required.
The full warning letter can be viewed here.
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