Estrella Food Products, Inc. – FDA Warning Letter, Nov 9, 2009

On March 26, 2010, the FDA issued a Warning Letter to Estrella Food Products, Inc. following an inspection from October 26 to November 9, 2009. The inspection revealed serious, repeat deviations causing products to be adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions, and misbranded under 21 U.S.C. § 343.

Sanitation violations included inadequate temperature controls (refrigeration at 70°F, freezers not maintaining frozen state, lack of monitoring for cooking/cooling times for meat/poultry mixtures) (21 CFR 110.80(b)(2)). Employee hygiene was deficient, with dirty outer garments, failure to wash hands before processing/packaging, and improper use of hair restraints (21 CFR 110.10(b)). The facility lacked adequate sanitary facilities, including no soap, sanitizer, or towels at handwashing stations, no toilet paper in restrooms, and no handwashing signs (21 CFR 110.37). Utensils were not properly sanitized, using only detergent instead of a sanitizing agent, and were rinsed with only water when detergent ran out (21 CFR 110.35(a)). Pest control was ineffective, with birds, flies, mosquitoes, and spider webs observed in