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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.
Sohgave 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.
In a Jan. 19 warning letter, the FDA described an Oct. 24-28, 2022, Foreign Supplier Verification Program (FSVP) inspection at Sohgave LLC located in Houston, 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. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop, maintain, and follow an FSVP for any foods that they import, including the following foods:
The full warning letter can be viewed here.
First Choice importing Inc.
Marlboro, NJ
An import company in New Jersey is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Jan. 12 warning letter, the FDA described a June 27 through Aug. 18, 2022, Foreign Supplier Verification Program (FSVP) inspection at First Choice importing Inc. in Marlboro, NJ.
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. 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, including funnel cake imported from their foreign supplier (redacted), located in (redacted), black tea imported from their foreign supplier (redacted), located in (redacted), and instant noodles imported from their foreign supplier (redacted), located in (redacted).
The full warning letter can be viewed here.
Salazar & Sons Corp.
Dinuba, 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 Dec. 29, 2022 warning letter, the FDA described a July 12 through Aug. 26, 2022, Foreign Supplier Verification Program (FSVP) inspection of Salazar & Sons Corp in Dinuba, CA.
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. 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, including:
The full warning letter can be viewed here.
selec Produce LLC
McAllen, 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 Jan. 3 warning letter, the FDA described an Aug. 29 through Sept. 12, 2022, Foreign Supplier Verification Program (FSVP) inspection of selec Produce LLC in McAllen, 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. 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, including:
The full warning letter can be viewed here.
Deliimports LLC
McAllen, 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 Dec. 12, 2022 warning letter, the FDA described a Sept. 12-28, 2022, Foreign Supplier Verification Program (FSVP) inspection of Deliimports, LLC in McAllen, 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. 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, including:
The full warning letter can be viewed here.
Compass Logistics LLC
McAllen, 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 Jan. 4 warning letter, the FDA described an Aug. 12-25, 2022, Foreign Supplier Verification Program (FSVP) inspection of Compass Logistics, LLC in McAllen, 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. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for the foods they import from the foreign suppliers indicated in the attached list, except for hot sauce imported from (redacted), including:
The full warning letter can be viewed here.
Rich River Produce LLC
Rio Rico, AZ
An import company in Arizona is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 4, 2022 warning letter, the FDA described a May 24, 2022, Foreign Supplier Verification Program (FSVP) inspection of Rich River Produce, LLC in Rio Rico, AZ.
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. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they stated they did not develop an FSVP for any foods that they import, including:
The full warning letter can be viewed here.
Corporate Essentials LLC
Parsippany, NJ
An import company in New Jersey is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Jan. 5 warning letter, the FDA described a June 29 to Sept. 22, 2022, Foreign Supplier Verification Program (FSVP) inspection of Corporate Essentials LLC in Parsippany, NJ.
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. 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, including:
The full warning letter can be viewed here.
Titans Global Inc.
City of Industry, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 27 warning letter, the FDA described a July 20 to Aug. 2, 2022, Foreign Supplier Verification Program (FSVP) inspection of Titans Global Inc. in City of Industry, CA.
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. 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, including each of the following food products:
The full warning letter can be viewed here.
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