Granules India's Hyderabad plant gets 11 US FDA observations

Granules India's finished dosage facility at Gagillapur, Hyderabad, received a Form 483 with 11 observations after a US FDA inspection from October 19 to 30, its first since a February 2025 warning letter. The company said none relate to data integrity or cross-contamination, manufacturing and supplies are unaffected, and it will respond within 15 business days.