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.
Supreme Fruit Produce Inc.
San Diego, CA
A food firm in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 1, 2022, warning letter, the FDA described a March 18-30, 2022, Foreign Supplier Verification Program (FSVP) inspection of Supreme Fruit Produce, Inc. in San Diego, 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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Fresh Chayote imported from (redacted) in (redacted);
- Fresh Serrano peppers imported from (redacted) in (redacted); and
- Fresh coconuts imported from (redacted) in (redacted);
The full warning letter can be viewed here.
Ruth Special Food Store LLC
Belleville, NJ
A food firm in New Jersey is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Dec. 9, 2022, warning letter, the FDA described a Aug. 25 through Sept. 19, 2022, Foreign Supplier Verification Program (FSVP) inspection of Ruth Special Food Store LLC in Belleville, 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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Organic shine skin pumpkin kernels, imported from (redacted), located in (redacted)
- Shine skin pumpkin kernels, imported from (redacted), located in (redacted)
- Dry roasted edamame, imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Nature’s Way Farms LLC
Pharr, TX
A food firm in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 21, 2022, warning letter, the FDA described a June 30 through July 11, 2022, Foreign Supplier Verification Program (FSVP) inspection of Nature’s Way Farms, LLC in Pharr, 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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
• Fresh bell peppers imported from (redacted) located in (redacted)
• Fresh avocados imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Del Valle Import Corp.
Bronx, NY
A food firm in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 1, 2022, warning letter, the FDA described a July 7 through Aug. 17, 2022, Foreign Supplier Verification Program (FSVP) inspection of Del Valle Import Corp. in Bronx, NY.
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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Dragon Fruit and Sweet Melons imported from (redacted), located in (redacted)
- Fresh Plantains imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
Sree Nidhi Corp.
Charlotte, NC
A food firm in North Carolina is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Aug. 25, 2022, warning letter, the FDA described an April 14-21, 2022, Foreign Supplier Verification Program (FSVP) inspection of Sree Nidhi Corp in Charlotte, NC.
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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
• Karivepaku with Garlic Spices imported from (redacted) located in (redacted).
• Semolina Course Wheat imported from (redacted) located in (redacted).
• Maize Atta Corn Flour imported from (redacted) located in (redacted).
• Frozen Mango Slices imported from (redacted) located in (redacted).
The full warning letter can be viewed here.
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