FDA EIR - Sun Pharmaceutical Industries Ltd. - June 11, 2019

An FDA pre-approval inspection of Sun Pharmaceutical Industries Ltd. in Halol, Gujarat, India, occurred from June 3-11, 2019, with a close-out meeting on June 22, 2019. This inspection, which focused on specific drug product applications including an injection and capsules, was conducted under regulatory frameworks for Pre-Approval Inspections and Drug Quality Reporting Systems, covering all six drug manufacturing systems. The inspection identified four significant observations detailed in a Form FDA 483. Key issues included a failure to adhere to procedures preventing microbial contamination in sterile drug products, inadequate documentation of established laboratory control mechanisms, insufficient design plans for development activities, and a lack of proper validation for processes not fully verifiable by subsequent inspection. These findings build upon a previous August 2018 inspection, which resulted in six observations regarding laboratory control test procedures, prevention of objectionable microorganisms in non-sterile products, stability program criteria, written production and process control procedures, and equipment cleaning protocols. Sun Pharmaceutical Industries Ltd. management acknowledged the 2019 observations and committed to submitting corrective actions to the FDA within 15 days. The company's registration remains current.