FDA sends warnings to import firms in Maryland, Michigan, and Texas

The Food and Drug Administration sends warning letters to entities below its jurisdiction as a part of its enforcement actions. Some letters usually are not posted for public view till weeks or months after they’re despatched. Business house owners have 15 days to reply to FDA warning letters. Warning letters usually usually are not issued till an organization has been given months to years to right issues.

Facema, LLC
Laurel, MD

An import firm in Maryland is on discover from the FDA for not having FSVPs for various imported meals merchandise.

In an Oct. 18, 2022, warning letter the FDA described a May 20 by way of Aug. 3, 2022, Foreign Supplier Verification Program (FSVP) inspection of Facema, LLC in Laurel, MD.

The FDA’s inspection revealed that the agency was not in compliance with FSVP rules and resulted in issuing an FDA Form 483a. Some of the numerous violations are as follows:

The agency didn’t develop an FSVP for any meals that they import, together with the next meals:

• Tomato sauce (with different elements) imported from (redacted), positioned in (redacted);
• Toffee sweet imported from Facema S.A. de C.V. positioned in Nicaragua; and
• Peanuts imported from (redacted) positioned in (redacted).

The full warning letter may be considered here.

ARYZ Trading LLC
Dearborn, MI

An import firm in Michigan is on discover from the FDA for not having FSVPs for various imported meals merchandise.

In a Sept. 21, 2022, warning letter the FDA described a June 29 by way of July 13, 2022, Foreign Supplier Verification Program (FSVP) inspection of ARYZ Trading LLC in Dearborn, MI.

The FDA’s inspection revealed that the agency was not in compliance with FSVP rules which resulted in the issuance of an FDA Form 483a. Some of the numerous violations are as follows:

The agency didn’t develop an FSVP for any meals that they import, together with the next meals:

• Dried mint imported from (redacted)
• Tahina imported from (redacted)
• Extra virgin olive oil imported from (redacted)

During the FDA inspection, investigators defined the FSVP regulation usually requires that the agency conduct a written hazard evaluation, consider their overseas provider’s efficiency, and conduct overseas provider verification actions. FDA investigators additionally defined that the agency should promptly take acceptable corrective actions in the event that they decide {that a} overseas provider of meals they import doesn’t produce the meals in compliance with processes and procedures that present not less than the identical stage of public well being safety as these required.

In relation, FDA investigators knowledgeable the agency that FDA analyzed a pattern of dried mint collected on 3/30/2022 from a cargo they imported on 3/15/2022, detected Salmonella, and decided the dried mint was adulterated. FDA investigators additionally advised them that FDA analyzed a pattern of their additional virgin olive oil collected on 5/20/2022 from a cargo they imported on 3/23/2022 and detected a pesticide chemical residue, which causes the article to be adulterated. Further, since FDA inspection, FDA analyzed a pattern of sesame seeds collected on 7/19/2022 from a cargo they imported on 05/24/2022, detected Salmonella and decided the sesame seeds have been adulterated.

The full warning letter may be considered here.

Minuti Coffee LLC
Houston, TX

An import firm in Texas is on discover from the FDA for not having FSVPs for various imported meals merchandise.

On Aug. 23, 2022, a warning letter the FDA described a May 12-20, 2022, Foreign Supplier Verification Program (FSVP) inspection of Minuti Coffee LLC in Houston, TX.

The FDA’s inspection revealed that the agency was not in compliance with FSVP rules which resulted in the issuance of an FDA Form 483a. Some of the numerous violations are as follows:

The agency didn’t develop an FSVP for any meals that they import, together with the next meals:

• Hot Chocolate (Cioco Delice White Chocolate), imported from Caffe Molinari S.P.A., Via Francia 20, Modena, Modena, 41122, Italy
• Decaf Coffee and Vinegar, imported from Caffe Molinari SPA, Via Manfredo Fanti 200/206, Modena, Modena, 41122, Italy

The full warning letter may be considered here.

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