FDA WARNING_LETTER - remnant inc. - December 06, 2017

On December 4-6, 2017, the FDA inspected Remnant Inc. DBA The Donut Stop's donut manufacturing facility, identifying serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering products adulterated under 21 U.S.C. § 342(a)(4). Additionally, products were found to be misbranded under 21 U.S.C. § 343 and 21 CFR Part 101.

Key violations include: - **Adulterated Food:** Failure to protect food from contamination (21 CFR 110.80(b)(13)) due to lack of an allergen control program, cross-contamination between raw and cooked products, and inadequate employee hygiene (e.g., not washing hands after touching hair/face). Reused, visibly soiled cardboard containers for packaging (21 CFR 110.80(b)(1)) and uncovered dough stored in contact with debris (21 CFR 110.80(b)(5)) were observed. Food-contact surfaces and utensils were not cleaned frequently enough (21 CFR 110.35(d)), with visible residue and build-up. Facility maintenance was poor (21 CFR 110.35(a)), including holes, peeling paint, soiled walls, and structural gaps