5 Items in Dr. Reddy’s Form FDA-483

FDA has issued Dr. Reddy's Laboratories a five-item Form FDA-483 after inspecting the firm’s drug substance and drug product manufacturing facility last month in Telangana, India. According to the FDA-483, the agency cited the following:

• The quality unit has not established adequate procedural controls and oversight to ensure the accuracy of environmental monitoring data.
• The firm failed to establish adequate document control procedures and oversight mechanisms to ensure appropriate management of written documents.
• Procedures designed to prevent microbial contamination did not include adequate aseptic techniques.
• Risk assessments for viral cross-contamination control are inadequate to mitigate potential virus cross-contamination risk to drug products.
• Written documents are inadequate to ensure proper documentation and analysis of critical manufacturing operations.

To view the FDA-483, click here.