FDA sends warning over import violations to firms in New York, Michigan and California

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


Rong Shing Buying and selling NY Inc.
Brooklyn, NY

An import firm in New York is on discover from the FDA for not having FSVPs for a lot of imported meals merchandise.

In a June 15 warning letter, the FDA described a March 9-24, 2021, distant Overseas Provider Verification Program (FSVP) inspection of Double R Buying and selling Inc (aka – Rong Shing Buying and selling NY Inc.) in Brooklyn, NY.

The FDA’s inspection revealed that the agency was not in compliance with FSVP laws and resulted within the issuance of an FDA Kind 483a. The numerous violations are as follows:

  1. The agency didn’t develop, keep, and comply with an FSVP. Particularly, they didn’t develop, keep, and comply with an FSVP for any of the meals merchandise they import, together with the next meals:
  • Combine sweet and Glam Day lollipops imported from (redacted), situated in (redacted).
  1. The agency didn’t meet the necessities to conduct and doc (or acquire documentation of) a number of of the provider verification actions listed in 21 CFR 1.506(e)(1)(i) via (iv) for every overseas provider earlier than importing the meals and periodically thereafter. Particularly, they didn’t conduct and doc (or acquire documentation of) a number of provider verification actions for his or her overseas provider (redacted) earlier than importing dried black fungus and periodically thereafter.

The complete warning letter will be seen right here.

Sobh Import Inc.
Dearborn, MI

An import firm in Michigan is on discover from the FDA for not having FSVPs for a lot of imported meals merchandise.

In a June 8 warning letter, the FDA described a March 22 via March 29, 2020, distant Overseas Provider Verification Program (FSVP) inspection of Sobh Import, Inc in Dearborn, MI.

The FDA’s inspection revealed that the agency was not in compliance with FSVP laws and resulted within the issuance of an FDA Kind 483a.

The numerous violations 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 they import, together with the next meals:

o Lokum Biscuit manufactured by (redacted),

o Sugar Coated Pistachio manufactured by (redacted), and

o Nougat with Cardamon manufactured by (redacted)

The complete warning letter will be seen right here.

Kuiyi Worldwide Inc.
Ontario, CA

An import firm in California is on discover from the FDA for not having FSVPs for a lot of imported meals merchandise.

In a June 29 warning letter, the FDA described a Feb. 11 to March 5, 2021, distant Overseas Provider Verification Program (FSVP) inspection of Kuiyi Worldwide Inc. in Ontario, CA.

The FDA’s inspection revealed that the agency was not in compliance with FSVP laws and resulted within the issuance of an FDA Kind 483a. The numerous violations are as follows:

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

  • Baked Rice Chips imported from (redacted), situated in (redacted)
  • Unif Kumquat Inexperienced Tea imported from (redacted), situated in (redacted)
  • Unif Sneaking Round Tea imported from (redacted), situated in (redacted)
  • (Redacted) Potato Chips, (redacted) imported from (redacted), situated in (redacted)

The complete warning letter will be seen right here.

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