Starlight Desserts Inc – FDA Warning Letter, Feb 13, 2018

The FDA inspected a bakery in Seattle from February 7-13, 2018, identifying serious Current Good Manufacturing Practice (cGMP) violations under 21 CFR Part 110, leading to adulterated food under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's response to the FDA-483 was deemed partially adequate or inadequate for all observations. Key violations included: 1) Failure to exclude pests, with live rodents and confirmed rat excreta found throughout the facility. 2) Employees not adhering to hygienic practices, such as failing to wash hands after touching their face or glasses, or after removing a bandage while handling ready-to-eat foods. 3) Inadequate cleaning of food-contact surfaces, evidenced by dough residue on equipment after sanitation. 4) Failure to maintain sanitary building fixtures, including dust and debris in a stove hood above uncovered in-process foods. 5) Inadequate and unsanitary toilet facilities, lacking hot water, paper towels, and proper cleanliness. 6) Failure to ensure plant construction allowed for adequate cleaning and repair, with observations of mold, rotting walls, missing ceiling panels, stagnant water, and an unsealed exterior door. The firm's responses lacked sufficient documentation of corrections, detailed recurrence prevention plans, or monitoring strategies. The FDA noted similar deviations in a previous inspection. The company must take prompt action, provide a written response within 15 business days detailing corrective actions, documentation, and recurrence prevention, or face potential regulatory actions like seizure or injunction, and reinspection fees.