FDA WARNING_LETTER - Christopher Dale Butler - September 23, 2025
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The FDA issued a Warning Letter to Christopher Dale Butler following an inspection of their ready-to-eat foods facility in El Dorado, Arkansas, conducted from September 10 to 23, 2025. The inspection revealed serious violations of the Emergency Permit Control (21 CFR Part 108) and Acidified Foods (21 CFR Part 114) regulations. The company"s pickled quail egg products were deemed adulterated under the Food, Drug and Cosmetic Act due to insanitary conditions. Key violations included the failure to establish a scheduled process by a qualified individual for their acidified products, a repeat observation from a previous inspection. Furthermore, the company failed to submit required scheduled process information to the FDA using Form FDA 2541e, despite facility registration. Additional issues noted were the failure to renew the facility"s registration for 2024, a violation of 21 CFR Part 1, Subpart H, and the absence of documented procedures for product recalls. The FDA requires Christopher Dale Butler to provide a written response within 15 working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to address these concerns could lead to legal action, including seizure or injunction.
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