FDA 483 - Amneal Oncology Private Limited - March 15, 2018

An FDA inspection conducted from March 8-15, 2018, at Amneal Oncology Private Limited in Hyderabad, Telangana, India, identified significant deviations from manufacturing quality standards at their drug manufacturing facility. The resulting FDA Form 483 detailed four primary observations requiring the company to implement corrective actions. Key issues included the absence of comprehensive written procedures for production and process controls, specifically concerning unsubstantiated filling ranges and inadequate qualification documentation for a labeling machine. The firm's quality control unit lacked sufficient oversight, failing to control versions or implement audit trails for critical Excel spreadsheets used in equipment performance qualification, raising concerns about data integrity. Additionally, deviations from established production and process control procedures, particularly during aseptic process simulation validations (media fills), were not adequately recorded or justified. Finally, the inspection revealed inadequate investigations into unexplained discrepancies, such as recurring communication errors in laboratory equipment software (Empower 3) and unaddressed spikes in water conductivity levels for water used in sterile drug product formulation. These observations indicate a need for Amneal Oncology Private Limited to implement robust corrective and preventive actions to ensure compliance with drug manufacturing regulations.