Lordi S. A. U – FDA EIR, Apr 29, 2014

Lordi Quesos, a cheese manufacturer in Los Yebenes, Spain, underwent its initial comprehensive FDA surveillance inspection from April 28-29, 2014. Conducted under FDA compliance policies for domestic and imported cheese and food safety, the inspection identified three primary observations. The regulatory framework cited included specific sections of 21 CFR Part 110, covering equipment design, pest control, and facility lighting.

Key issues noted on the FDA-483 Inspectional Observations form included plastic dividers, which make contact with cheese, not being easily removable for proper cleaning; inadequate pest exclusion due to gaps in exterior doors in sensitive areas like packaging and maturation rooms; and insufficient lighting, with two non-functional fluorescent lights in the packing area.

Management, led by Director General Mr. Juan López-Rey Diezma and Quality Control Manager Mr. José López-Ray Diezma, committed to promptly addressing these issues. Required actions included correcting the equipment design within two to three weeks, sealing pest entry points within two weeks, and restoring adequate lighting within 24 hours. Management promised to provide photographic evidence of these corrections to the FDA. The firm exports pasteurized cow, goat, and sheep milk cheeses to the United States.