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The API manufacturer was flagged for not qualifying suppliers of critical raw materials or contracted laboratories used to manufacture and test several finished APIs marketed in the U.S. Read More
Contract API manufacturer Precise Packaging failed to test raw materials and to document out-of-specification investigations, the FDA found in an inspection of the firm’s Fall River, Massachusetts plant. Read More
It is expected that preliminary conclusions of the inspections “ will be jointly agreed on-site by the inspecting authorities,” the WHO said. Read More
Trinidad-based OTC drug manufacturer CGA drew a warning letter from the FDA for serious GMP lapses including inadequate testing and producing an unapproved drug. Read More
The FDA issued Australian contract OTC drugmaker Tismor Health and Wellness a warning letter for serious GMP violations and data integrity lapses. Read More
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