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

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.

Facema, LLC
Laurel, MD

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

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

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

The firm did not develop an FSVP for any foods that they import, including the following foods:

Tomato sauce (with other ingredients) imported from (redacted), located in (redacted);Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; andPeanuts imported from (redacted) located in (redacted).

The full warning letter can be viewed here.

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

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

The firm did not develop an FSVP for any foods that they import, including the following foods:

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

During the FDA inspection, investigators explained the FSVP regulation generally requires that the firm conduct a written hazard analysis, evaluate their foreign supplier’s performance, and conduct foreign supplier verification activities. FDA investigators also explained that the firm must promptly take appropriate corrective actions if they determine that a foreign supplier of food they import does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required.

In relation, FDA investigators informed the firm that FDA analyzed a sample of dried mint collected on 3/30/2022 from a shipment they imported on 3/15/2022, detected Salmonella, and determined the dried mint was adulterated. FDA investigators also told them that FDA analyzed a sample of their extra virgin olive oil collected on 5/20/2022 from a shipment 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 sample of sesame seeds collected on 7/19/2022 from a shipment they imported on 05/24/2022, detected Salmonella and determined the sesame seeds were adulterated.

The full warning letter can be viewed here.

Minuti Coffee LLC
Houston, TX

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

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 firm was not in compliance with FSVP regulations which resulted in the issuance of an FDA Form 483a. Some of the significant violations are as follows:

The firm did not develop an FSVP for any foods that they import, including the following foods:

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

The full warning letter can be viewed here.

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