FDA 483 - Macleods Pharmaceuticals Limited - May 26, 2023

Macleods Pharmaceuticals Limited in Daman, India, was cited for deficiencies in equipment design and control during an FDA inspection. Issues included checkweigher failures without proper batch record instructions, lack of dynamic airflow testing in manufacturing areas, and undefined critical alarms for automated equipment. The firm also failed to maintain complete lists of automated equipment recipes and lacked continuous monitoring for differential pressures, indicating a need for improved manufacturing process oversight.