FDA WARNING_LETTER - Fomar Import/Export Inc. - September 09, 2013

The FDA conducted an inspection at Fomar Import/Export Inc.'s food facility warehouse from August 28 to September 09, 2013. The inspection revealed and sample analyses confirmed that products held at the facility were adulterated under Section 402(a)(3) [21 U.S.C. 342 (a)(3)] due to insect filth, and Section 402(a)(4) [21 U.S.C. 342 (a)(4)] because they were prepared, packed, or held under insanitary conditions. A Form FDA-483 was issued detailing gross insanitary conditions. Key violations included live and dead insects, larva, and frass in/on/near foods, rodent pellets, and pest ingress points. Additionally, loose food products were found on floors, dirt, dust, and cobwebs were prevalent, insects were on packing tables, and rubbish/debris was improperly stored. These findings indicate a failure to adequately clean or control pests. The firm's action to destroy some product and fumigate others was noted, but additional pest prevention measures are recommended. Failure to promptly correct these deviations may result in regulatory actions like seizure or injunction. Fomar Import/Export Inc. must respond in writing within 15 working days, outlining specific corrective actions and recurrence prevention steps, or explain any delays.