As a part of its enforcement actions, the Meals and Drug Management sends caution letters to entities beneath its jurisdiction. Some letters aren’t posted for public view till weeks or months after they’re despatched. Trade house owners have 15 days to reply to FDA caution letters. Caution letters regularly aren’t issued till an organization has been given months to years to proper issues. The FDA regularly redacts portions of caution letters posted for public view.
Fella Workforce LLC
Irvine, CA
An import corporate in California is on understand from the FDA for now not having FSVPs for a variety of imported meals merchandise.
In a Feb. 25, 2022, caution letter the FDA described a Dec. 10, 2021, International Provider Verification Program (FSVP) inspection of Fella Workforce LLC in Irvine, CA.
The FDA’s inspection published that the company used to be now not in compliance with FSVP rules and resulted within the issuance of an FDA Shape 483a. One of the important violations are as follows:
The company didn’t broaden, care for, and practice an FSVP. In particular, they didn’t broaden an FSVP for each and every of the next meals:
- Mayocoba Beans imported from (redacted)
- Chick Peas (Garbanzo Beans) imported from (redacted)
- Rustic Salad Dressing imported from (redacted) and
- another meals they import
The total caution letter may also be seen right here.
Teahouse Tapioca and Tea Inc.
Houston, TX
An import corporate in Texas is on understand from the FDA for now not having FSVPs for a variety of imported meals merchandise.
In a Dec. 20, 2021, caution letter the FDA described a Nov. 8-18, 2021, International Provider Verification Program (FSVP) inspection of Teahouse Tapioca and Tea Inc. in Houston, TX.
The FDA’s inspection published that the company used to be now not in compliance with FSVP rules and resulted within the issuance of an FDA Shape 483a. One of the important violations are as follows:
The company didn’t broaden, care for, and practice an FSVP. In particular, they didn’t broaden an FSVP for each and every of the next meals:
- Mango Powder Combine imported from overseas provider (redacted) situated in (redacted)
- Inexperienced Apple Syrup imported from (redacted) situated in (redacted)
- Medium Tapioca imported from (redacted) situated in (redacted)
The total caution letter may also be seen right here.
Euphrates Meals LLC dba Labeeb Alani Inc.
Morton Grove, IL
An import corporate in Illinois is on understand from the FDA for now not having FSVPs for a variety of imported meals merchandise.
In a Dec. 23, 2021, caution letter the FDA described a Sept. 7-27, 2021, International Provider Verification Program (FSVP) inspection of Euphrates Meals LLC dba Labeeb Alani Inc. in Morton Grove, IL.
The FDA’s inspection published that the company used to be now not in compliance with FSVP rules and resulted within the issuance of an FDA Shape 483a. One of the important violations are as follows:
The company didn’t broaden, care for, and practice an FSVP. In particular, they didn’t broaden an FSVP for each and every of the next meals:
- Roasted white pumpkin seeds and nuts in-shell imported from (redacted)
- Pistachio toffee imported from (redacted)
The total caution letter may also be seen right here.
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