FDA investigators found API production records all over the floor, desks and cabinets of the quality unit in Yibin Lihao Bio-technical’s Sichuan, China facility. Read More

Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database. Read More

Therapiva Private, an active pharmaceutical ingredient manufacturer in India, was hit with a Form 483 by the FDA for quality control unit and cleaning lapses. Read More

The FDA issued a warning letter to an over-the-counter drug manufacturer in Eastern China for multiple testing violations at its facility. Read More

The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers. Read More

New Jersey drugmaker Health Pharma USA drew a warning letter from the FDA for serious lapses in its quality unit and poor batch records. Read More

Switzerland’s drug agency Swissmedic rapped an Indian drugmaker for significant CGMP violations at a facility near Mumbai. Read More

The FDA has issued Form 483 inspection reports to seven drug companies for a variety of GMP and other lapses, including problems with data integrity, complaint handling and visual examinations of finished drug products. Read More