The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have failed to comply with good manufacturing norms ...

FDA has also sent several Form 483s, the precursor to most Warning Letters, to Indian companies such as one to Ranbaxy in January 2014. The letters stick out because unlike manufacturing ...

Two-day training with real-world cases and practical application organized in collaboration with Prescription Pharma Support ...

Connected quality environments, AI governance, and evolving digital capabilities are changing risk identification, ...

Pharmaceutical major Pfizer has been issued a warning letter by US FDA on issues of failed sterility test, Environmental ...