FDA 483 - Aarkish Pharmaceuticals NJ Inc - August 18, 2022

Aarkish Pharmaceuticals NJ Inc, a drug manufacturer in Fairfield, NJ, was cited for numerous significant deficiencies during an FDA inspection. Observations included inadequate batch production records, lack of validated procedures for water system sanitization and quality event closure, incomplete laboratory data, and insufficient data integrity controls for electronic records. Additionally, the firm failed to maintain proper environmental controls in manufacturing rooms, ensure appropriate drug product storage temperatures, and adequately clean and maintain manufacturing equipment.