FDA WARNING_LETTER - Zarda Foods LLC - July 18, 2012

The FDA inspected Zarda Foods, LLC in Blue Springs, Missouri, on July 17-18, 2012, and documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation, 21 CFR Part 110. These failures render the firm's food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. An FDA-483 was issued on July 18, 2012, detailing the observations. Key violations included the failure to manufacture, package, and store food products under conditions necessary to minimize contamination, as evidenced by baked beans being held at elevated temperatures (e.g., (b)(4) degrees Fahrenheit) for extended periods without reaching required refrigeration. Additionally, the firm failed to adequately use a sanitizing agent, specifically not following instructions for food contact surfaces. The FDA requires prompt corrective action and a written response within 15 working days detailing the steps taken, including documentation and a timetable for any remaining corrections. Failure to implement lasting corrective actions may lead to regulatory actions such as product seizure or injunction against the firm. A follow-up inspection is planned to verify the adequacy of corrective actions related to the sanitizing agent.