FDA WARNING_LETTER - Seattle Roll Bakery - August 23, 2011
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On January 25, 2012, the FDA issued a Warning Letter to Seattle Roll Bakery following an inspection conducted on August 20, 21, and 23, 2011. The inspection revealed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), causing food products to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Additionally, the labeling for Ban Tieu, Chao Quay, and Vietnamese Sandwich products was found to be misbranded under Section 403 of the Act and 21 CFR Part 101.
Key violations included: - **Pest Control (21 CFR 110.35(c), 110.20(b)(7)):** Live and dead rodents, rodent excreta pellets, flies, and cockroaches were observed throughout the facility, including in dough preparation and on food contact surfaces. The front door was left open, and a hole in the wall allowed pest entry. - **Protection Against Contamination (21 CFR 110.80(b)(5), 110.35(d), 110.35(b)(2), 110.40(a), 110.20(b)(5), 110.
ID · 206bf614-fe36-4dd3-be32-5aca6f3ee790
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