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 continuously aren’t issued till an organization has been given months to years to right kind issues.
Triple J Recent LLC
Hidalgo, TX
An import corporate in Texas is on realize from the FDA for now not having FSVPs for numerous imported meals merchandise.
In an April 25, caution letter, the FDA described a Jan. 6-7 Overseas Provider Verification Program (FSVP) inspection of Triple J Recent in McAllen, TX.
The FDA’s inspection printed that the company used to be now not in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t increase, care for, and apply an FSVP. In particular, they didn’t increase an FSVP for each and every of the next meals, together with each and every of the next meals:
- Recent broccoli and recent coriander imported from (redacted), positioned in (redacted)
- Recent Persian limes imported from (redacted), positioned in (redacted)
The whole caution letter may also be considered right here.
El Dorado Imports Inc.
Houston, TX
An import corporate in Texas is on realize from the FDA for now not having FSVPs for numerous imported meals merchandise.
In an April 26 caution letter, the FDA described a Dec. 9-17, 2021, Overseas Provider Verification Program (FSVP) inspection of El Dorado Imports Inc. in Spring, TX.
The FDA’s inspection printed that the company used to be now not in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t increase, care for, and apply an FSVP. In particular, they didn’t increase an FSVP for any of the meals merchandise they import, together with each and every of the next meals merchandise:
- Coconut sweet imported from (redacted)
- Sugar baked flour tortillas imported from (redacted)
- Candy bread with pineapple imported from (redacted)
The whole caution letter may also be considered right here.
Lempira Distribution LLC
Miami, FL
An import corporate in Florida is on realize from the FDA for now not having FSVPs for numerous imported meals merchandise.
In a Nov. 3 caution letter, the FDA described a June 9 via July 16, 2021, Overseas Provider Verification Program (FSVP) inspection of Lempira Distribution LLC in Miami, FL.
The FDA’s inspection printed that the company used to be now not in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t increase, care for, and apply an FSVP. In particular, they didn’t increase an FSVP for the meals merchandise that they import, together with, however now not restricted to:
- Banana Comfortable Drink, imported from (redacted), positioned in (redacted)
- Candy Bread, imported from (redacted), positioned in (redacted)
- (Redacted) Plantain Chips, imported from (redacted)
The whole caution letter may also be considered right here.
LECS USA Inc.
Los Angeles, CA
An import corporate in California is on realize from the FDA for now not having FSVPs for numerous imported meals merchandise.
In a March 28 caution letter, the FDA described a Nov. 10, 2021, Overseas Provider Verification Program (FSVP) inspection of LECS USA Inc. in Los Angeles, CA.
The FDA’s inspection printed that the company used to be now not in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t increase, care for, and apply an FSVP. In particular, they didn’t increase an FSVP for any of the meals they import, together with:
- (Redacted) Inexperienced Tea imported from international providers, (redacted)
The whole caution letter may also be considered right here.
Fres Co. LLC
Bronx, NY
An import corporate in New York is on realize from the FDA for now not having FSVPs for numerous imported meals merchandise.
In an April 18 caution letter, the FDA described a Dec. 7, 2021, via Jan. 24, 2022, Overseas Provider Verification Program (FSVP) inspection of Fres Co. LLC in Bronx, NY.
The FDA’s inspection printed that the company used to be now not in compliance with FSVP laws and resulted within the issuance of an FDA Shape 483a. The numerous violations are as follows:
The company didn’t increase, care for, and apply an FSVP. In particular, they didn’t increase an FSVP for any of the meals they import, together with:
- Recent plantains from (redacted)
- Recent mangoes from (redacted)
- Tomatoes from (redacted)
The whole caution letter may also be considered right here.
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