FDA WARNING_LETTER - East Asia Noodle Co Inc - May 31, 2012
The FDA inspected East Asia Noodle Co., Inc. from May 24-31, 2012, finding significant deviations from cGMP regulations (21 CFR Part 110) and food labeling regulations (21 CFR Part 101). These violations render the foods adulterated under 21 U.S.C. § 342(a)(4) and misbranded under 21 U.S.C. § 343.
cGMP violations include: 1. Employees failing to use suitable outer garments to prevent food contamination (21 CFR 110.10(b)(1)), observed with an employee's arm in food mixture and another's shirt touching product. 2. Lack of appropriate food handling and protection training for employees (21 CFR 110.10(c)), despite a language barrier. 3. Failure to provide hand washing facilities where needed (21 CFR 110.0(e)(1)), specifically no sink in the upstairs bathroom, though one was installed during inspection. 4. Failure to provide effective hand preparations (soap) for employees (21 CFR 110.37(e)(2)), observed at the production area hand washing station and first-floor bathroom, though corrected during inspection.
Labeling violations include: 5. Egg Roll Skins, Fried Noodles,
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