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.
Maliba African Market Corp.
New York, NY
An import company in New York is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 7, 2022, warning letter, the FDA described an Aug. 18 through Aug. 25, 2022, Foreign Supplier Verification Program (FSVP) inspection of Maliba African Market Corp. in New York, NY.
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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Fonio from (redacted) located in (redacted)
- Mayonnaise (redacted) from (redacted) located in (redacted)
- Seasoning powder/no meat/(redacted) from (redacted) located in (redacted)
The full warning letter can be viewed here.
Pepe’s Foods Inc.
Hayward, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In an Oct. 19, 2022, warning letter, the FDA described a July 14-21, 2022, Foreign Supplier Verification Program (FSVP) inspection of Pepe’s Foods Inc. in Hayward, CA.
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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- (redacted) Loroco, imported from (redacted), located in (redacted)
- Frozen Chipilin (redacted), imported from (redacted), located in (redacted)
- Red Beans, imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
K2 Trading Inc.
Hackensack, NJ
An import company in New Jersey is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 7, 2022, warning letter, the FDA described a May 4-25, 2022, Foreign Supplier Verification Program (FSVP) inspection of K2 Trading Inc. in Hackensack, NJ.
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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Korean rice cake imported from (redacted), located in (redacted).
- Caramel imported from (redacted), located in (redacted).
- Malt powder imported from (redacted), located in (redacted).
- Glutinous rice flour imported from (redacted), located in (redacted).
- Rice flour imported from (redacted), located in (redacted).
The full warning letter can be viewed here.
Manzela USA, LLC
McAllen, TX
An import company in Texas is on notice from the FDA for not having FSVPs for a number of imported food products.
In a Nov. 7, 2022, warning letter, the FDA described a June 15-24, 2022, Foreign Supplier Verification Program (FSVP) inspection of Manzela USA, LLC in McAllen, TX.
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. Some of the significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for each of the following foods:
- Com Chips imported from foreign supplier Manzela S.A. de C.V., located in Mexico
- (Redacted) Candy imported from foreign supplier (redacted) located in (redacted)
- Peanuts imported from foreign supplier Manzela S.A. de C.V., located in Mexico
The full warning letter can be viewed here.
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