Three Californian firms are given warnings because of lack of FSVPs

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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.

Ventura Terra Garden Inc.

Ventura, CA

An import company in California is on notice from the FDA for not having Foreign Supplier Verification Programs for a number of imported food products. The inspection was initiated because of imported enoki mushrooms being associated with a multinational Listeria monocytogenes outbreak.

In the July 29 warning letter the FDA described an April 15-17, 20-21, and 29, 2020, Foreign Supplier Verification Program (FSVP) inspection at Ventura Terra Garden Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

  1. The firm did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a control. The firm may rely on the hazard analysis of your foreign supplier to meet their obligations under the FSVP regulation, however, they did not provide FDA with any evidence that they documented their review and assessment of their foreign supplier’s hazards analysis. They may meet their requirement to conduct a hazard analysis, by reviewing and assessing their supplier’s hazard analysis and documenting their review and assessment of that hazard analysis.
  2. An onsite audit of the firm’s foreign supplier, (redacted), did not consider an applicable food safety regulation. Specifically, their third-party “Audit Checklist Report” (redacted) dated April 4, 2019, for their enoki mushrooms imported from (redacted), did not include the Food Safety Modernization Act (FSMA) Produce Safety Rule as part of the criteria.
  3. The firm did not promptly document their review and assessment of the results of a verification activity that was conducted by another entity. Specifically, they did not have documentation that they reviewed and assessed the result of third-party (redacted) audit for their Enoki mushroom imported from, (redacted).

The full warning letter can be viewed here.

Kaymile Trading Inc.

South El Monte, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a July 28 warning letter the FDA described an April 24, 2020, Foreign Supplier Verification Program (FSVP) inspection at Kaymile Trading Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in issuance of an FDA Form 483a. The significant violations are as follows:

  1. The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
  2. Roasted onion granules imported from (redacted) located in (redacted).
  3. Coarse black pepper imported from (redacted) located in (redacted).
  4. For the roasted garlic granules imported from (redacted), located in (redacted), they did not meet their requirements to conduct a hazard analysis. During the inspection, they provided a copy of their foreign supplier’s HACCP plan. They may meet their requirement to conduct a hazard analysis by reviewing and assessing their supplier’s hazard analysis and documenting their review and assessment of their supplier’s hazard. The firm did not provide documentation that they have reviewed and assessed their foreign supplier’s hazard analysis.
  5. The firm must approve their  foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, and document their approval. They did not document their approval of their foreign supplier of roasted garlic granules imported from (redacted).
  6. The firm did not establish and follow written procedures to 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.
  7. They did not establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the foods they import.
  8. The firm did not conduct and document (or obtain documentation of) one or more of the supplier verification activities listed for each foreign supplier before importing the food and periodically thereafter. For example, they did not conduct and document (or obtain documentation of) one or more of such supplier verification activities for their foreign supplier (redacted), before importing roasted garlic granules and periodically thereafter.

The full warning letter can be viewed here.

Pasha Food Distribution USA Inc.

Tarzana, CA

An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.

In a May 18 warning letter the FDA described a March 18, 2020, Foreign Supplier Verification Program (FSVP) inspection at Ventura Terra Garden Inc.

The FDA’s inspection revealed that the firm was not in compliance with FSVP regulations and resulted in 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 develop an FSVP for roasted eggplant manufactured by (redacted), and dried sumac and tahini manufactured by (redacted).

If a firm is a very small importer and they choose to comply with the modified requirements, they must document that they meet the definition of very small importer as required. In addition, for each food they import, they must obtain written assurance, before importing the food and at least every two years thereafter, that their foreign supplier is producing the food in compliance with processes and procedures that provide at least the same level of public health protection. 

The full warning letter can be viewed here.

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