26-Oct-2026 11:13:54
ZYDUS LIFESCIENCES: USFDA FLAGS SERIOUS DATA INTEGRITY ISSUES AT MORAIYA PLANT; ISSUES 5 OBSERVATIONS
• USFDA Inspection: Issued 5 observations following inspection of the Moraiya manufacturing facility in Gujarat during October 5–13, 2026 • US Revenue Exposure: Approximately 45% of Zydus's US sales reportedly originate from products manufactured at Moraiya • Data Integrity Issues: Microbial growth detected during testing was allegedly not accurately recorded in laboratory records • Product Quality: FDA flagged inadequate investigation of metal contamination in a tablet that resulted in a Class II recall • Quality Control Failures: Multiple batches exceeding established assay control limits reportedly entered the US market without adequate root-cause investigations • Compliance Gaps: Inadequate written procedures for identifying, investigating and reporting suspect or illegitimate drug products • Equipment Validation: FTIR instruments used for raw-material identification reportedly lacked documented performance verification for three years • Raw Material Testing: Reduced testing continued despite previous specification failures, contrary to company procedures • Regulatory Risk: Observations raise concerns over manufacturing compliance, potential regulatory action and future US product approvals
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