In a recent enforcement action aimed at enhancing food safety standards, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies: Zest US Wholesale Inc., Xin Ao International Group Corp., Gongora USA Corp., and San Juan Produce LLC.
These companies have been cited for serious violations of the Foreign Supplier Verification Program (FSVP), which mandates that importers ensure that food imported into the United States meets specific safety standards equivalent to domestic requirements.
The enforcement highlights continuing noncompliance issues that have persisted despite prior inspections and opportunities to rectify mistakes.
#### Zest US Wholesale Inc.
Zest US Wholesale Inc., based in Anaheim, California, came under FDA scrutiny during an inspection on April 28. The investigation revealed that the company did not develop, maintain, or adhere to an FSVP for any of its incoming food products, which included milk chocolate bars with peanuts, pistachio spread cream, and coconut almond truffles sourced from foreign suppliers.
Following the inspection, the FDA issued a Form FDA 483a outlining the violations; however, the company has yet to respond. Moreover, the FDA identified that Zest US Wholesale had not met food facility registration requirements, despite being alerted to this obligation during the inspection.
#### Xin Ao International Group Corp.
Between April 23 and May 6, the FDA inspected Xin Ao International Group Corp. in Staten Island, New York, uncovering similar problems. The company failed to develop an FSVP for its imported products such as seafood mushrooms and enoki mushrooms.
The FDA also issued a Form FDA 483a, warning that continued noncompliance could result in the detention of imported products without physical examination under Import Alert #99-41.
#### Gongora USA Corp.
Gongora USA Corp., located in Chula Vista, California, was inspected from November 14 to 15, 2024. This inspection followed an earlier audit between December 2020 and January 2021, where the company also failed to create an FSVP for imported fresh produce, which included fresh cucumbers and white squash.
A Form FDA 483a was issued without any response from the company. Notably, some of Gongora's imports may be classified as “covered produce” under the Produce Safety Rule, which necessitates supplier verification for compliance with U.S. safety standards.
#### San Juan Produce LLC
San Juan Produce LLC, based in McAllen, Texas, was inspected on March 25, where it was found that the company did not have an FSVP for its fresh produce imports, including Husk tomatoes, carrots, and cilantro.
The FDA provided a Form FDA 483a, yet, like the others, San Juan Produce has not responded. The agency pointed out that some of the imports may fall under the “covered produce” category under the Produce Safety Rule.
Although San Juan Produce indicated that it might qualify as a “very small importer,” it could not provide supporting documentation to validate this status or comply with modified requirements.
### Implications for Manufacturers
These warnings underscore the importance of compliance with FDA regulations and the potential consequences of neglecting FSVP requirements.
For pharmaceuticals, biotechnology, and medical device manufacturers involved in importing raw materials or finished products, these enforcement actions serve as a crucial reminder of the need for rigorous safety protocols and regulatory adherence.
As the FDA intensifies scrutiny, companies must prioritize establishing and maintaining robust verification processes to ensure imported products meet the necessary safety standards, thereby safeguarding public health and maintaining market access.
- By News Desk