C K Frozen Fish and Food Inc. – FDA Warning Letter, Mar 7, 2023

On February 13, 2023, through March 7, 2023, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of C K Frozen Fish and Food Inc. at 16856 Douglas Ave., Jamaica, NY 11433. The inspection aimed to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1, subpart L).

The inspection revealed significant violations: C K Frozen Fish and Food Inc. did not develop, maintain, and follow an FSVP for any imported foods, as required by section 805 of the FD&C Act and 21 CFR section 1.502(a). This non-compliance was documented in a Form FDA 483a, FSVP Observations, dated March 7, 2023.

The company's March 14, 2023, email response to the FDA 483a was deemed inadequate, as it only stated an intent to start corrective action "as soon as possible" without providing specific proposed actions, a timeframe, or steps taken to develop FSVPs.

Failure to adequately address these violations may result in further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD