FDA WARNING_LETTER - FOODWORKS INTERNATIONAL LLC - July 23, 2019

On October 16, 2019, the FDA issued a Warning Letter to Mr. Panithan (Dan) Narmsthien following a Foreign Supplier Verification Program (FSVP) inspection on July 23, 2019, at 3670 131st Ave N, Clearwater, FL. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found significant violations, specifically that the firm failed to develop an FSVP as required by 21 CFR 1.502(a) for imported products including Canned Jackfruit in Syrup and Canned Palm Seeds in Syrup from (b)(4), and Sweet Chili Sauce in Glass Bottles from (b)(4). This finding was consistent with a previous inspection on March 5, 2018.

The firm received a Form FDA 483a, FSVP Observations, at the conclusion of both the initial and follow-up inspections but did not submit a response. Failure to correct these violations may result in the refusal of admission for the listed products under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) under Import Alert # 99-41.

The FDA requires a written response within fifteen working days detailing corrective actions, including documentation such