FDA warns companies in New York and California about foreign supplier regulations

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.

Willis Ocean Inc., Brooklyn, NY
William Cheng, owner

In an April 30 warning letter the FDA described a March 5  Foreign Supplier Verification Program inspection (FSVP) at Willis Ocean Inc., as well as an initial inspection on Dec. 13 and 21, 2017. Inspectors found that the company was still not in compliance with FSVP regulations.

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

Significant FSVP regulation violations described by inspectors 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:

• Frozen Vegetarian Food (redacted)
• Chinese Noodle (redacted)

The full warning letter can be viewed here.

Kradjian Importing Company Inc., Glendale, CA
Raffi Kradjian, CEO and president

In a May 4 warning letter the FDA described a Jan. 30 Foreign Supplier Verification Program inspection at Kradjian Importing Company Inc. Inspectors found that the company was not in compliance with FSVP regulations.

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

Significant FSVP regulation violations described by inspectors are as follows:

1. The firm did not develop, maintain, and follow an FSVP for tahina imported from foreign supplier (redacted) or for canned chickpeas/garbanzo beans imported from foreign supplier (redacted). Specifically, the firm did not develop an FSVP for either product. In addition, for the canned chickpeas/garbanzo beans, they did not verify and document that the food was produced in accordance with FSVP requirements. 
2. For the tahina from their foreign suppliers, (redacted), the firm did not meet your requirements to conduct a hazard analysis because they did not evaluate their foreign supplier’s performance, nor did they perform foreign supplier verification activities. During FDA inspection they provided copies of documents including a hazard analysis for tahina that was conducted by their foreign suppliers, (redacted). They did not provide FDA with any evidence that they documented their review and assessment of their foreign supplier’s hazard analysis. The FSVP regulation also generally requires that they evaluate their foreign supplier’s performance and conduct foreign supplier verification activities. The firm failed to meet these requirements.

The full warning letter can be viewed here.

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