FDA 483 - Fareva Morton Grove - August 12, 2025

An FDA inspection of Fareva Morton Grove revealed critical deficiencies in their manufacturing processes, particularly concerning the water system design and microbial control. The firm failed to adequately identify gram-negative rod organisms in water samples and did not test drug products for objectionable microorganisms like Burkholderia cepacia. Additionally, significant issues were noted in record-keeping for equipment cleaning, laboratory data, and the stability program, indicating a lack of robust quality control and potential risks to product safety and integrity.