As part of its enforcement activities, the Food and Drug Administration sends out alerting letters to entities under its jurisdiction. Some letters are not published for public view up until weeks or months after they are sent out. Company owner have 15 days to react to FDA cautioning letters. Caution letters frequently are not provided till a business has actually been provided months to years to remedy issues.
Grace Supply Inc.
Missouri City, TX
An import business in Texas is on notification from the FDA for not having FSVPs for a number of imported food.
In a Jan. 8 caution letter, the FDA explained Aug. 16 and Sept. 6, 2023, Foreign Supplier Verification Program (FSVP) evaluations of Grace Supply Inc. in Missouri City, TX.
The FDA’s assessment exposed that the company was not in compliance with FSVP policies and led to the issuance of an FDA Form 483a.
A few of the substantial offenses are as follows:
1. The company did not establish, preserve, and follow an FSVP as needed. Particularly, they did not establish an FSVP for any foods that they import, other than for the following foods:
- Bonus hot treat mix imported from (edited by FDA) (edited by FDA)
- Shredded frozen coconut imported from (edited by FDA) (edited by FDA)
- Banana chips imported from (edited by FDA) and (edited by FDA) (edited by FDA)
While they supplied FSVP files for additional hot treat mix imported from (edited by FDA)situated in (edited by FDA) and shredded frozen coconut from (edited by FDA)situated in (edited by FDA)these files do not satisfy the FSVP requirements, as talked about listed below.
2. The company’s danger analysis for the shredded frozen coconut from (edited by FDA)situated in (edited by FDA)did not recognize and assess coconut as a possible chemical risk (food irritant) to identify whether the threat needs a control. A danger analysis should recognize recognized or fairly foreseeable threats for each kind of food they import to identify whether there are any dangers needing a control. The analysis of the recognized or fairly foreseeable threats in each food need to consist of biological risks, chemical risks (consisting of pesticide residues), and physical dangers. Particularly, coconut is a tree nut and is acknowledged by FDA as a food irritant. Their risk analysis for shredded frozen coconut and the risk analysis offered by their foreign provider did not determine and assess coconut as a prospective chemical threat.
3. The company did not satisfy the requirements to perform and record (or acquire paperwork of) several of the provider confirmation activities noted for each foreign provider before importing the food and regularly afterwards. The company’s FSVP for the additional hot treat mix imported from (edited by FDA)situated in (edited by FDA)recorded that they identified “a mix of tasting and screening and evaluation of appropriate food security records is the suitable confirmation activity” with a frequency of “quarterly up until a history is developed and yearly afterwards.” They did not carry out and record (or get paperwork of) one or more such provider confirmation activities for their foreign provider. The company FSVP consisted of a copy of a self-assessment audit report for the additional hot treat mix imported from (edited by FDA)nevertheless, the audit was performed at their provider’s moms and dad business, (edited by FDA)not their provider (edited by FDA)Even more, they did not file or offer records of any tasting and screening outcomes. They did not carry out and record or get documents of one or more provider confirmation activities before importing their additional hot treat mix imported from (edited by FDA) into the United States, as needed.
4. The company’s provider confirmation activities did not offer sufficient guarantee that the dangers needing a control in the foods they import have actually been considerably decreased or avoided, as needed. Particularly, they figured out that for their shredded frozen coconut from (edited by FDA)there is a threat, particularly Salmonella, that will be managed by the foreign provider. Salmonella is a danger that leads to severe unfavorable health repercussions or death to people or animals (SAHCODHA).
The complete caution letter can be seen here
Mexpobaja Corporation
Oakland, CA
An import business in California is on notification from the FDA for not having FSVPs for numerous imported foodstuff.
In a Jan 23 cautioning letter, the FDA explained an Aug. 29-31, 2023, Foreign Supplier Verification Program (FSVP) assessment of Mexpobaja Corporation in Oakland, CA.
The FDA’s assessment exposed that the company was not in compliance with FSVP policies and led to the issuance of an FDA Form 483a.
A few of the considerable infractions are as follows:
The company did not establish, keep, and follow an FSVP, as needed. Particularly, they did not establish an FSVP for any of the foods from the foreign providers listed below:
- Pitahaya (Dragonfruit), imported from (edited by FDA)situated in (edited by FDA)
- Pasilla Chili Peppers (Poblano), imported from (edited by FDA)situated in (edited by FDA)
- Jalapeno Peppers imported from (edited by FDA)situated in (edited by FDA)
The complete caution letter can be seen here
A True Move LLC
Houston, TX
An import business in Texas is on notification from the FDA for not having FSVPs for a number of imported food.
In a Dec. 18, 2023 caution letter, the FDA explained an Oct. 12-13, 2023, Foreign Supplier Verification Program (FSVP) examination of A True Move LLC in Houston, TX.
The FDA’s evaluation exposed that the company was not in compliance with FSVP policies and led to the issuance of an FDA Form 483a.
A few of the substantial infractions are as follows:
The company did not establish, preserve, and follow an FSVP, as needed. Particularly, they did not establish an FSVP for any of the foods from the foreign providers listed below:
- Banana Sodas imported from (edited by FDA)situated in (edited by FDA)
- Lollipops imported from (edited by FDA)situated in (edited by FDA)
- Tomato Paste imported from (edited by FDA)situated in (edited by FDA)
The complete caution letter can be seen here
JJR Global Inc.
Missouri City, TX
An import business in Texas is on notification from the FDA for not having FSVPs for numerous imported foodstuff.
In a Dec. 1, 2023 caution letter, the FDA explained an Aug. 9-10, 2023, Foreign Supplier Verification Program (FSVP) evaluation of JJR Global Inc. in Missouri, TX.
The FDA’s evaluation exposed that the company was not in compliance with FSVP guidelines and led to the issuance of an FDA Form 483a.
A few of the substantial offenses are as follows:
The company did not establish, keep, and follow an FSVP, as needed. Particularly, they did not establish an FSVP for any of the foods from the foreign providers listed below:
- (edited by FDA)Sweet Mango Chutney, and Coriander Chutney (Frozen) from (edited by FDA) situated in (edited by FDA)
The complete caution letter can be seen here
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