FDA sends warning letters to Illinois, Texas firms about import violations

As a part of its enforcement actions, the Meals and Drug Administration sends warning letters to entities underneath its jurisdiction. Some letters aren’t posted for public view till weeks or months after they’re despatched. Enterprise house owners have 15 days to answer FDA warning letters. Warning letters typically aren’t issued till an organization has been given months to years to right issues. The FDA regularly redacts elements of warning letters posted for public view.


MnM Spices Corp.
Addison, IL

An import firm in Illinois is on discover from the FDA for not having FSVPs for a variety of imported merchandise, together with steam rice, dates and pine nuts.

In a Might 18 warning letter, the FDA described a Feb. 19-22, 2021, Overseas Provider Verification Program (FSVP) inspection of FSVP data MnM Spices Company submitted electronically to the FDA. The FDA had additionally performed an inspection on Aug. 20 and 23, 2018.

On each events, the FDA’s inspection revealed that the agency was not in compliance with FSVP rules and resulted within the issuance of an FDA Type 483a.

The agency’s important violations of the FSVP regulation are as follows:

The agency didn’t develop, keep, and comply with an FSVP, as required. Particularly, the agency didn’t develop an FSVP for any meals that they import, together with steam rice (plain), dates, and pine nuts (shelled) imported from (redacted), positioned in (redacted).

Primarily based on the agency’s (redacted), (redacted).

As a accountable official of a facility that manufactures/processes, packs, or holds meals for human or animal consumption in the US, the corporate is liable for guaranteeing that its total operation and the merchandise it distributes are in compliance with the regulation.

(Redacted)

The above violations aren’t meant to be an all-inclusive checklist of violations of the FSVP necessities. It’s the agency’s accountability to make sure that they’re in compliance with part 805 of the FD&C Act.

This letter notifies the agency of FDA considerations and offers them a possibility to deal with them. Failure to deal with this matter adequately might result in regulatory motion. As an illustration, the FDA might take motion underneath part 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the meals merchandise they import, together with steam rice (plain), dates, and pine nuts (shelled) from their international provider (redacted), positioned in (redacted), that look like in violation of part 805. The FDA might place these meals they import on detention with out bodily examination (DWPE) once they import the merchandise.

The total warning letter could be considered right here.

Lux Industrial Group LLC
Mission, TX

An import firm in Texas is on discover from the FDA for not having FSVPs for a variety of imported merchandise, together with mango drink, corn chips and corn flour.

In a Might 18 warning letter, the FDA described a March 2-3, 2021, Overseas Provider Verification Program (FSVP) inspection of data Lux Industrial Group LLC submitted electronically to the FDA. The FDA had additionally performed an inspection on March 4, 2019.

On each events, the FDA’s inspection revealed that the agency was not in compliance with FSVP rules and resulted within the issuance of an FDA Type 483a.

The agency’s important violations of the FSVP regulation are as follows:

The agency didn’t develop, keep, and comply with an FSVP as required. Particularly, they didn’t develop an FSVP for any of the meals merchandise they import, together with:

  • (redacted) mango drink imported from (redacted), positioned in (redacted)
  • (redacted) corn chips imported from (redacted), positioned in (redacted)
  • corn flour imported from (redacted), positioned in (redacted)

The total warning letter could be considered right here.

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