The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. 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.
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The Food and Drug Administration has sent a warning letter to MKK Imports of Torrance, CA, for failure to meet the Foreign Supplier Verification Program (FSVP) requirements.
On March 26, 2023, the FDA conducted the business’s Foreign Supplier Verification Program (FSVP). Investigators also conducted inspections on Aug.15, 2018, and Dec. 19, 2019. These inspections were conducted to determine compliance with Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384a) requirements and the implementing FSVP regulation in 21 CFR part 1, subpart L.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. Information relating to the FSVP regulation and responsibilities to comply with the regulation can be found through links on the FDA’s FSVP web page at https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals
During the most recent inspection, the FDA found that the company does not comply with the 21 CFR part 1 requirements, subpart L, for the foods it imports. Because of these significant violations, the company does not comply with section 805 of the FD&C Act.
After the inspection, an FDA investigator provided the company with a Form FDA 483a FSVP Observations.
The FDA has not received the company’s response to Form FDA 483a, issued on March 26, 2023.
Significant violations of the FSVP regulation are as follows:
The company did not develop, maintain, and follow an FSVP as required by Section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, the company did not develop an FSVP for any foods that you import, including:
- Orange Fruit Jelly imported from (b)(4)
- Fried Potato Chips imported from (b)(4)
- Baked Wheat Cracker imported from (b)(4)
The above violations are not intended to be an all-inclusive list of violations of the FSVP requirements. The company is responsible for ensuring that it complies with section 805 of the FD&C Act and the implementing regulation in 21 CFR part 1, subpart L.
The letter notified the company of the FDA’s concerns and allowed it to address them. The FDA may take further action if the company does not adequately address this matter. For instance, the agency may take action under section 801(a)(3) of the FD&C Act (21 U.S.C. 381(a)(3)) to refuse admission of the food the company imports for which the company appears to violate section 805. The FDA may place the foods the company imports into the United States on detention without physical examination (DWPE) when the company imports the foods. The company can find DWPE information about FSVP in Import Alert # 99 41 at http://www.accessdata.fda.gov/cms_ia/ialist.html. In addition, the importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the FD&C Act or the FSVP regulation is prohibited under section 301(zz) of the FD&C Act (21 U.S.C. 331(zz)).
The complete warning letter can be read by clicking here.
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