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.
Dream Wholesale Inc.
Warren, 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 Feb. 15 warning letter, the FDA described a May 16 and Aug. 2, 2023, Foreign Supplier Verification Program (FSVP) inspection of Dream Wholesale, Inc. in Warren, 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.
Some of the significant violations are as follows:
1. The firm’s analysis of the known or reasonably known foreseeable hazards in each food they import as described below did not include the types of hazards pursuant to regulation. They must conduct a written hazard analysis for each type of food they import to determine whether any hazards require a control. Their hazard analysis must identify known or reasonably foreseeable hazards for each type of food they import to determine whether any hazards require a control. The analysis of the known or reasonably foreseeable hazards in each food must include biological hazards, chemical hazards and physical hazards. A hazard means any biological, chemical, or physical agent that is reasonably likely to cause illness or injury. Specifically, while they provided FDA with their hazard analyses for the food they import, the hazard analyses they provided for their (redacted by FDA) soda water, cooked chickpeas, grape leaves, dried apricot paste and frozen spinach, each state “Biological,” “Chemical,” and “Physical” but do not describe elements that appear to be hazards. For example, their hazard analysis for cooked chickpea lists “B=Biological: shelf life, C=Chemical: preservatives, P=Physical: packed in cans” but does not list any specific hazards (e.g., specific microorganisms or pathogens). To adequately determine which hazards require a control, the hazard analysis should identify the specific relevant hazard (e.g., the relevant microorganisms or pathogens). They indicated they are waiting for the hazard analyses from their foreign suppliers. Therefore, the FDA finds their analysis of the known or reasonably foreseeable hazards in each food did not include the types of hazards pursuant to regulation.
2. The firm did not establish and follow written procedures to ensure that they import foods only from approved foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food and document their use of these procedures. Specifically, they have not established written procedures for approving foreign suppliers for any of their imported foods, including for green cardamom from (redacted by FDA), (redacted by FDA) soda water from (redacted by FDA), cooked chickpeas from (redacted by FDA), grape leaves from (redacted by FDA), dried apricot paste from (redacted by FDA) and frozen spinach from (redacted by FDA). During the inspection, they were unable to provide records of their evaluation of their foreign suppliers’ performance and the risk posed by the foods they import.
3. The firm did not meet the requirements to perform foreign supplier verification activities for the products they import. Specifically, they did not document their determination or performance of appropriate supplier verification activities for green cardamom from (redacted by FDA), (redacted by FDA) soda water from (redacted by FDA), cooked chickpeas from (redacted by FDA), grape leaves from (redacted by FDA), dried apricot paste from (redacted by FDA) and frozen spinach from (redacted by FDA).
The full warning letter can be viewed here.
Cavevi Naturals LLC
St. Hedwig, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 8, 2023 warning letter, the FDA described an Aug. 4-9, 2023, Foreign Supplier Verification Program (FSVP) inspection of Cavevi Naturals LLC in St. Hedwig, TX.
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.
Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for any of the foods they import:
- (Redacted by FDA) candy imported from (redacted by FDA), located in (redacted by FDA)
- (Redacted by FDA) candy imported from (redacted by FDA), located in (redacted by FDA)
- Cheetos Nacho chips imported from (redacted by FDA), located in (redacted by FDA)
The full warning letter can be viewed here.
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