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.
Rong Shing Trading NY Inc.
Brooklyn, 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 June 15 warning letter, the FDA described a March 9-24, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Double R Trading Inc (aka – Rong Shing Trading NY Inc.) in Brooklyn, 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. The significant violations are as follows:
- The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop, maintain, and follow an FSVP for any of the food products they import, including the following foods:
- Mix candy and Glam Day lollipops imported from (redacted), located in (redacted).
- The firm did not meet the requirements to conduct and document (or obtain documentation of) one or more of the supplier verification activities listed in 21 CFR 1.506(e)(1)(i) through (iv) for each foreign supplier before importing the food and periodically thereafter. Specifically, they did not conduct and document (or obtain documentation of) one or more supplier verification activities for their foreign supplier (redacted) before importing dried black fungus and periodically thereafter.
The full warning letter can be viewed here.
Sobh Import Inc.
Dearborn, MI
An import company in Michigan is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 8 warning letter, the FDA described a March 22 through March 29, 2020, remote Foreign Supplier Verification Program (FSVP) inspection of Sobh Import, Inc in Dearborn, MI.
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 significant violations 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 foods they import, including the following foods:
o Lokum Biscuit manufactured by (redacted),
o Sugar Coated Pistachio manufactured by (redacted), and
o Nougat with Cardamon manufactured by (redacted)
The full warning letter can be viewed here.
Kuiyi International Inc.
Ontario, CA
An import company in California is on notice from the FDA for not having FSVPs for a number of imported food products.
In a June 29 warning letter, the FDA described a Feb. 11 to March 5, 2021, remote Foreign Supplier Verification Program (FSVP) inspection of Kuiyi International Inc. in Ontario, 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. The significant violations are as follows:
The firm did not develop, maintain, and follow an FSVP as required. Specifically, they did not develop, maintain, and follow an FSVP for any of the products they import, including each of the following food products:
- Baked Rice Chips imported from (redacted), located in (redacted)
- Unif Kumquat Green Tea imported from (redacted), located in (redacted)
- Unif Sneaking Around Tea imported from (redacted), located in (redacted)
- (Redacted) Potato Chips, (redacted) imported from (redacted), located in (redacted)
The full warning letter can be viewed here.
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