Three companies from Texas, Illinois and New Mexico have violated import regulations, FDA says

Texas – In an intricate web of regulatory oversight, the Food and Drug Administration (FDA) routinely exercises its jurisdictional purview by dispatching warning letters to entities that it believes are in violation of federal standards.

Often obscured from the public eye for several weeks to months post-dispatch, these cautionary missives mandate that business proprietors furnish a formal response within a constrained window of fifteen days. It should be noted that such warnings are typically the culmination of a protracted period—spanning months, if not years—during which a company is accorded the latitude to rectify the outlined deficiencies.

Eco Food Distribution LLC – Schiller Park, IL

Emerging as the latest subject of such scrutiny is Eco Food Distribution LLC, a Schiller Park, Illinois-based import firm, which has drawn federal ire for its failure to institute a Foreign Supplier Verification Program (FSVP) for the array of international foods it imports. In a warning letter dated May 25, the FDA meticulously detailed the findings of an FSVP inspection conducted over a one-month span, commencing on February 28 and culminating on March 29.

The crux of the FDA’s inspection disclosed the disconcerting reality that Eco Food Distribution LLC remains noncompliant with the stipulations embedded in FSVP regulations. This revelation led to the issuance of an FDA Form 483a, a formal document enumerating significant violations that warrant immediate attention. Key infringements encapsulated in this form are as follows:

1. A conspicuous absence of a developed, maintained, and duly followed FSVP, particularly concerning the importation of foods from explicitly indicated foreign suppliers.
2. A glaring lack of written hazard analyses for each variety of food imported, aimed at ascertaining any hazards that might necessitate control measures. For instance, the firm neglected to produce a written hazard analysis concerning the chocolate-covered gingerbread apples and carrot nectar they source from undisclosed foreign suppliers. This absence violates the requirement to appraise known or reasonably foreseeable hazards.
3. A deficient approval process for foreign suppliers, predicated upon an absence of a comprehensive evaluation of the supplier’s performance and associated food-related risks. Documentation substantiating these evaluations and approvals was conspicuously absent, specifically regarding the aforementioned chocolate-covered gingerbread apples and carrot nectar.
4. An unequivocal failure to execute requisite foreign supplier verification activities. The firm did not delineate, document, nor implement the verification activities essential for assuring the compliance of their foreign suppliers with prevailing regulations. Furthermore, there was no evidence of either conducting or procuring documentation of any such verification activities for each of their foreign suppliers prior to the importation of these edibles and periodically thereafter.

The full warning letter can be viewed here.

Moises Gardea – Albuquerque, NM

In the case of Moises Gardea, an import entity operating out of Albuquerque, New Mexico, the FDA unveiled its concerns in a sternly-worded warning letter dated June 12, which summarized the findings of an FSVP inspection conducted between March 9 and March 24. The FDA’s inquiry led to the issuance of an FDA Form 483a, a document enumerating significant transgressions requiring immediate action.

The inspection unequivocally demonstrated that Moises Gardea fell markedly short of complying with FSVP regulations. This pertained specifically to the company’s failure to develop, maintain, and execute an FSVP for multiple foods such as Asadero Cheese—both Solid and Tortilla Style—as well as Mennonite Cheese, all of which were imported from undisclosed foreign suppliers.

The full warning letter can be viewed here.

FVD Produce LLC – Pharr, TX

Concurrently, the FDA has also set its regulatory sights on FVD Produce LLC, a Pharr, Texas-based import firm. In an August 15 warning letter, the agency cataloged the outcomes of a two-part FSVP inspection spanning February 8 and March 9. Like its Albuquerque counterpart, FVD Produce was also served with an FDA Form 483a, accentuating several glaring deficiencies in compliance.

Specifically, the inspection revealed that FVD Produce had not developed, maintained, or followed an FSVP for a medley of fresh produce, encompassing fresh tomatoes, husk tomatoes, carrots, and various onions. These items were sourced from unidentified foreign suppliers, thereby further compromising the traceability and safety protocols.

The full warning letter can be viewed here.

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