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.
MnM Spices Corp.
Addison, IL
An import company in Illinois is on notice from the FDA for not having FSVPs for a number of imported products, including steam rice, dates and pine nuts.
In a May 18 warning letter, the FDA described a Feb. 19-22, 2021, Foreign Supplier Verification Program (FSVP) inspection of FSVP records MnM Spices Corporation submitted electronically to the FDA. The FDA had also conducted an inspection on Aug. 20 and 23, 2018.
On both occasions, 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.
The firm’s significant violations of the FSVP regulation are as follows:
The firm did not develop, maintain, and follow an FSVP, as required. Specifically, the firm did not develop an FSVP for any foods that they import, including steam rice (plain), dates, and pine nuts (shelled) imported from (redacted), located in (redacted).
Based on the firm’s (redacted), (redacted).
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, the company is responsible for ensuring that its overall operation and the products it distributes are in compliance with the law.
(Redacted)
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. It is the firm’s responsibility to ensure that they are in compliance with section 805 of the FD&C Act.
This letter notifies the firm of FDA concerns and provides them an opportunity to address them. Failure to address this matter adequately may lead to regulatory action. For instance, the FDA may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food products they import, including steam rice (plain), dates, and pine nuts (shelled) from their foreign supplier (redacted), located in (redacted), that appear to be in violation of section 805. The FDA may place these foods they import on detention without physical examination (DWPE) when they import the products.
The full warning letter can be viewed here.
Lux Commercial Group LLC
Mission, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported products, including mango drink, corn chips and corn flour.
In a May 18 warning letter, the FDA described a March 2-3, 2021, Foreign Supplier Verification Program (FSVP) inspection of records Lux Commercial Group LLC submitted electronically to the FDA. The FDA had also conducted an inspection on March 4, 2019.
On both occasions, 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.
The firm’s significant violations of the FSVP regulation are as follows:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop an FSVP for any of the food products they import, including:
- (redacted) mango drink imported from (redacted), located in (redacted)
- (redacted) corn chips imported from (redacted), located in (redacted)
- corn flour imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
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