FDA 483 - Sun Pharmaceutical Industries Limited - August 12, 2022

The FDA Form 483 inspection revealed multiple deficiencies at the facility.

**Observation 1** details a failure to thoroughly review unexplained discrepancies. An investigation into alleged backdating by QA and QC personnel, initiated by Disclosure 2020-01 on January 22, 2020, confirmed instances of backdating but was not comprehensive. It failed to interview all alleged QA reviewers, evaluate claims of avoiding documentation to ensure timely product release, or thoroughly review other work by employees who initially denied backdating. A corporate quality audit identified non-contemporaneous recording but lacked specific actions to determine the extent of ongoing or past backdating.

**Observation 2** highlights that established sampling plans, test procedures, and laboratory control mechanisms are not documented at the time of performance. Building access records contradict documented sample collection times and locations, showing employees in different buildings or lacking required access for documented sample collection.

**Observation 3** states that written procedures are not drafted, reviewed, and approved by appropriate organizational units and the quality control unit. Annual Product Quality Reviews (APQRs) for a specific product revealed that its manufacturing process is not capable of consistently meeting dissolution specifications based on calculated process capability (Cpk).

**Observation 4** indicates deficient laboratory records, specifically that they do not include a complete record of all data obtained during testing. When an analyst changes a chromatography processing method for impurity analysis, the original chromatogram is not saved, even though results