Neocis Inc. – FDA 483, Aug 5, 2022

An FDA inspection of Neocis Inc., a specification developer in Miami, FL, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to establish effective CAPA processes, resulting in multiple instances where CAPAs were closed as effective but the underlying issues, such as mislabeling, product registration difficulties, and equipment leaks, recurred or remained unresolved. This indicates a systemic breakdown in the company's ability to address and prevent quality problems.