06-Nov-2026 10:03:14
GRANULES INDIA: USFDA ISSUES FORM 483 WITH 11 OBSERVATIONS AT GAGILLAPUR FACILITY - CNBC-TV18 🔴🔴
• USFDA Inspection: Conducted at Granules India's Gagillapur manufacturing facility from October 19–30, 2026 • Regulatory Findings: USFDA issued Form 483 containing 11 observations • Data Integrity: Unexplained discrepancies were not adequately investigated; out-of-specification investigations found incomplete • Manufacturing Controls: Inadequate process control procedures and failure to follow established manufacturing requirements • Equipment Maintenance: Written maintenance procedures not followed; routine equipment inspections found insufficient • Quality Control: Deficiencies identified in quality control unit responsibilities, authority and implementation of procedures • Product Specifications: Inadequate compliance with established drug product specifications and purity requirements • Contamination Risk: Equipment cleanliness deficiencies raised concerns about possible product contamination • Process Compliance: Manufacturing and quality control procedures were not consistently followed • Regulatory Status: Form 483 observations require corrective responses; issuance does not itself constitute a final FDA enforcement action
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