FDA 483 - Sigan America Llc - September 01, 2022

Sigan America LLC, a human drug manufacturer in Ottawa, IL, was cited for significant deficiencies in its quality control systems. Observations included a lack of established procedures for preventing objectionable microorganisms in non-sterile drug products, specifically regarding routine testing for B. cepacia. Additionally, the firm's equipment cleaning and maintenance procedures were found to be deficient, lacking adequate cleaning validation and root cause analysis for repeated microbial failures.