FDA 483 - Lloyd Inc. of Iowa - February 02, 2018

Lloyd Inc., a manufacturer of animal and human drugs in Shenandoah, IA, was cited for significant deficiencies during an FDA inspection. Observations included inadequate contamination control in manufacturing areas, a poorly designed HVAC system, and a failure to investigate air pressure reversals. Additionally, the firm lacked scientifically sound laboratory controls, including unvalidated impurity testing methods, insufficient component specifications, and unapproved changes to drug formulations.