Foreign supplier verification violations prompt FDA warning letters

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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.

88 Special Sweet Inc., South El Monte, CA
Stella Sotoodeh, CEO

In a May 13 warning letter the FDA described a Jan. 9 and 21 Foreign Supplier Verification Program inspection at 88 Special Sweet Inc., as well as an initial inspection on Sept. 13, 2018. Inspectors found that the company was not in compliance with FSVP regulations.

FDA’s inspection resulted in issuance of an FDA Form 483a. 

The significant FSVP regulation violations noted 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:

  • Sunny Popping Balls (Boba) Strawberry Flavor products imported from (redacted).
  • Mango Syrup and Passion Fruit Jam products imported from (redacted).

The full warning letter can be viewed here.

D.K. Grocery Inc. dba Apna Bazaar Cash and Carry, Edison, NJ
Khadag Singh, president

In a May 14 warning letter the FDA described a Feb. 27 Foreign Supplier Verification Program inspection at D. K. Grocery Inc. dab Apna Bazaar Cash and Carry, as well as an initial inspection on Aug. 9, 2018. Inspectors found that the company was not in compliance with FSVP regulation.

FDA’s inspection resulted in issuance of an FDA Form 483a. 

The significant FSVP regulation 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:

  • Chick Peas, Moth Whole Polished (aka Moth beans), and Chana Dal imported from your foreign supplier (redacted), located in (redacted).

The full warning letter can be viewed here.

Maspeth Wholesale Corp.
Desh Deepak Bhardwaj, president

In a May 14 warning letter the FDA described a March 4 Foreign Supplier Verification Program inspection at Maspeth Wholesale Corp, as well as an initial inspection on July 25, 2018. Inspectors found that the company was not in compliance with FSVP regulation.

FDA’s inspection resulted in issuance of an FDA Form 483a. 

The significant FSVP regulation violations are as follows:

The firm did not develop, maintain, and follow an FSVP. Specifically, they did not develop an FSVP for the following product:

  • Chili powder manufactured by (redacted).

The full warning letter can be viewed here.

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