As part of its enforcement activities, FDA issues warning letters to entities under its jurisdiction. Some letters are not released for public viewing until weeks or months after they are mailed. Business owners have 15 days to respond to the FDA warning letter. Warning letters are usually issued after the company has been given months to years to correct the problem.
Flores Produce
Chula, CA Vista
An import company in California received FDA notification
in 2022 In a warning letter dated June 24, the FDA described the March 8-11, 2022 Foreign Supplier Verification Program (FSVP) for Flores Produce Inc.
located in Chula Vista, California. )
checking. An FDA inspection revealed that the company did not comply with FSVP regulations and resulted in the issuance of FDA Form 483a. Major violations are as follows:
The company did not develop, maintain and follow the FSVP. Specifically, they did not formulate a FSVP for each of the following foods:
- Papaya (redacted) imported from
Supplementary explanation:
The company imports papaya, which is a “covered agricultural product”. Their FSVP must demonstrate that their suppliers adhere to processes and procedures in producing food that provide at least the same level of public health protection as required (with regard to the Produce Safety Standard) and the Grow, Harvest Standard for implementing regulations, packaging and preservation Products for human consumption.
The full warning letter can be viewed here.
North30 LLC
- Bellevue, WA
An import in Washington The company was notified by the FDA that some imported foods did not have FSVP.
In a warning letter dated June 24, 2022, FDA described the March 14-April 8, 2022 Foreign Supplier Verification Program (FSVP) Inspection by North30 LLC of Bellevue.
FDA inspection revealed that the company did not comply with FSVP regulations and resulted in the issuance of FDA Form 483a. Major violations are as follows:
The company did not develop, maintain and follow the FSVP. Specifically, they did not formulate a FSVP for each of the following foods:
- Passion jam, imported from (redacted)
- at (redacted) Taro, imported from (REDACTED) at (REDACTED) Mesona extract, imported from (REDACTED), at (REDACTED)
The full warning letter can be viewed here.
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