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.

IMAD International LLC
Bronx, 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 March 29 warning letter, the FDA described a Jan. 14 2021, remote Foreign Supplier Verification Program (FSVP) inspection for IMAD International LLC.

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:

  1. For the plantain chips imported from the firm’s foreign supplier (redacted), they did not develop, maintain, and follow an FSVP as required. Because (redacted) appears to be on the CFIA list of firms in good standing, they may be eligible to follow the modified requirements in 21 CFR 1.513 for that product.
  2. For the melon seeds and honey beans imported (redacted), the firm did not meet their requirements to conduct a hazard analysis in accordance with 21 CFR 1.504(a). During the inspection, they provided a copy (redacted) Food Safety Analysis – Hazard Analysis. They may meet their requirement to conduct a hazard analysis, as required, by reviewing and assessing their supplier’s hazard analysis and documenting their review and assessment of their supplier’s hazard analysis as required.
  3. The firm must approve their foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505(a), and document their approval, as required. They did not document their approval of their foreign supplier of melon seeds and honey beans imported (redacted), as required.
  4. The firm did not establish and follow written procedures to ensure that they import foods only from foreign suppliers they have approved based on an evaluation of the foreign supplier’s performance and the risk posed by the food, conducted in accordance with 21 CFR 1.505, and document their use of these procedures, as required.
  5. The firm did not establish and follow written adequate procedures ensuring that foreign supplier verification activities are conducted with respect to the food they import as required.
  6. 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, as required. Specifically, they did not conduct and document (or obtain documentation) of one or more supplier verification activities for their foreign supplier (redacted) before importing melon seeds and honey beans periodically thereafter.

The full warning letter can be viewed here.

(To sign up for a free subscription to Food Safety News, click here)