Lucky K.T. Co., Inc.
Lucky K.T. Co., Inc., a food manufacturing facility in El Monte, CA, received an FDA Warning Letter following an April–May 2023 inspection that found serious violations of Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls regulations for its noodle products (Fresh Rice Noodle, Rice Stick Noodle, Egg Noodle, Chow Mein Noodle, and Pancit Noodle). The FDA determined the products were adulterated due to insanitary conditions — including pest infestations, unclean equipment, and inadequate pathogen controls — and misbranded due to undeclared allergens (wheat), incorrect ingredient declarations, and non-compliant Nutrition Facts labels. FDA required a written response within 15 working days detailing corrective actions, warning that failure to comply could result in seizure or injunction.
Flagged claims (5)
your Egg Noodle (5 lb.) and Pancit Noodle (16 oz./1 lb.) products are manufactured using enriched flour, which contains "wheat;" however, the finished product labels for Egg Noodle (5 lb.), Pancit Noodle (16 oz./1 lb.) do not declare the major food allergen wheat.
Your Egg Noodle (5 lb.) and Rice Stick Noodle (16 oz./1 lb.) product labels do not include the following required information: Total Sugars, Added Sugars, Potassium, and Vitamin D, in accordance with 21 CFR 101.9(c). The labels also include a declaration of "Calories from Fat" which is no longer permitted in the updated nutrition facts label (NFL), and the footnote is not in accordance with 21 CFR 101.9(d)(9).
The product label declares "fresh eggs" while your product formulation indicates the product is manufactured using (b)(4).
The product label declares "potato starch" which is not listed as an ingredient on the product formulation.
If a label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label shall appear in the foreign language, as required by 21 CFR 101.15(c)(2). For example, the Nutrition Facts labels must be declared in all languages.
Required actions (2)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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