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.
Both of the following warning letters address violations of the Foreign Supplier Verification Program (FSVP). FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.
Dinamix Distribution LLC — McAllen, TX
The Food and Drug Administration sent a warning letter dated Dec. 12, 2019, to the owner of Dinamix Distribution LLC, Rodulfo Suarez.
During a Foreign Supplier Verification Program (FSVP) inspection at Dinamix Distribution LLC on June 28, 2019, FDA investigators found that the company was not in compliance with federal law for the following products imported from the companies foreign suppliers: mayonnaise; tomatoes-spice flavored drink; and punch flavored soft drinks imported from (redacted). The company also did not have FSVPs for these products.
The FDA received a company response dated Aug. 8, 2019, regarding the FDA 483a FSVP observations form issued June 28, 2019. But, it did not address the lack of FSVPs for the imported products’ according to the FDA warning letter.
In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.
The violations noted by the FDA:
“You did not develop an FSVP as required by section 805 of the FD&C Act and 21 CFR part I subpart L. Specifically, your firm did not develop an FSVP for each of the following foods:”
- “mayonnaise manufactured by (redacted)”
- “tomatoes-spice flavored drink (redacted) manufactured by (redacted)”
- “punch flavored soft drinks manufactured by (redacted)”
A complete list of the violations can be found in the FDA’s warning letter.
Swagath Home Foods LLC — Redmond, WA
The Food and Drug Administration sent a warning letter dated Jan. 7, 2019, to the Managing Partner of Swagath Home Foods LLC, Ravi Modalavalasa.
During a Foreign Supplier Verification Program (FSVP) inspection at Swagath Home Foods LLC, FDA investigators found that the company was not in compliance with the requirements of federal law for their black pepper powder imported from Subhash Masala Co. Pvt. Ltd., spiced chutney powder imported from MTR Foods Pvt. Ltd., and potato chips imported from Pepsico India Holding Pvt. The company did not have FSVPs for the products.
In response to these deviations, the FDA issued an FDA 483 Inspectional Observations form that lists deviations observed at the facility.
The violations noted by the FDA:
- The FDA received a response dated Sept. 28, 2019, which included a document entitled “Swagath Foreign Supplier Verification Program Guidelines.” The document stated that the company intends to undertake certain verification-related steps, such as: verifying FDA’s website for any known banned products for import hazard, “enforc[ing] hazard analysis for each and every product imported,” and “not importing products that are flagged for risk.” However, this response was deemed inadequate because the company did not demonstrate that they have performed any FSVP requirements for particular products.
- We also note that the guidelines the company provided were very general and do not reflect all of the requirements in the FSVP rule.
A complete list of the violations can be found in the FDA’s warning letter.
(To sign up for a free subscription to Food Safety News, click here.)
