FDA RESUME - Unknown Company

The FDA's Office of Regulatory Affairs (ORA) in the Kansas City District conducted a series of inspections and investigations under the leadership of CDR Lisa L. Flores, a Consumer Safety Officer and Federal Investigator. The inspections, which took place from December 1, 2015, to the present, focused on a variety of regulated products, including food, drugs, cosmetics, and medical devices. Key violations identified included the presence of Listeria strains at a food manufacturing facility, which necessitated a regulatory meeting with the firm's management.

The inspections adhered to FDA's regulatory framework, ensuring compliance with agency laws, regulations, and policies. Flores led a team in conducting inspections of high-risk food establishments in Greece and Italy, aiming to preemptively address food safety issues before products entered the U.S. market. The investigations also extended to consumer complaints and complex cases involving dual jurisdiction, requiring coordination with state and local public health officials and other federal agencies.

As an acting supervisor, Flores managed administrative duties and provided training and guidance to subordinate staff. She also served as an emergency response coordinator, liaising with regional and headquarters emergency coordinators and ensuring district readiness for emergencies.

The FDA requires the inspected firms to address the identified violations, particularly concerning food safety standards, and to comply with agency-enforced laws. The agency emphasizes the importance of maintaining open communication with industry representatives to provide guidance on compliance issues.