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. The FDA frequently redacts parts of warning letters posted for public view.
Fella Group LLC
Irvine, 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 Feb. 25, 2022, warning letter the FDA described a Dec. 10, 2021, Foreign Supplier Verification Program (FSVP) inspection of Fella Group LLC in Irvine, 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:
- Mayocoba Beans imported from (redacted)
- Chick Peas (Garbanzo Beans) imported from (redacted)
- Rustic Salad Dressing imported from (redacted) and
- any other foods they import
The full warning letter can be viewed here.
Teahouse Tapioca and Tea Inc.
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 Dec. 20, 2021, warning letter the FDA described a Nov. 8-18, 2021, Foreign Supplier Verification Program (FSVP) inspection of Teahouse Tapioca and Tea Inc. 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. 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:
- Mango Powder Mix imported from foreign supplier (redacted) located in (redacted)
- Green Apple Syrup imported from (redacted) located in (redacted)
- Medium Tapioca imported from (redacted) located in (redacted)
The full warning letter can be viewed here.
Euphrates Foods LLC dba Labeeb Alani Inc.
Morton Grove, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Dec. 23, 2021, warning letter the FDA described a Sept. 7-27, 2021, Foreign Supplier Verification Program (FSVP) inspection of Euphrates Foods LLC dba Labeeb Alani Inc. in Morton Grove, IL.
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:
- Roasted white pumpkin seeds and nuts in-shell imported from (redacted)
- Pistachio toffee imported from (redacted)
The full warning letter can be viewed here.
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