Manufacturing Compliance In Brief: Seven US FDA Warning Letters, Two EU GMP Non-Compliance Notices
Executive Summary
Cross-contamination problems figure prominently in notices from US and European agencies that were sent to firms in India and other Asian countries.
You may also be interested in...
Chinese API Maker Blasted For Failing To Document Equipment Cleaning And Lax Stability Testing Practices
FDA chastised Chinese API maker for inadequate cleaning validation, failing to ensure that products are manufactured in a state of control, and lax stability testing practices. The agency noted that the firm did not learn from observations the agency made of similar mistakes during previous inspections.
Manufacturing Compliance Updates In Brief From US FDA And The EU
FDA issues five more drug GMP warning letters to drug manufacturers and active ingredient manufacturers at sites in India, China, and the US exhorting them to do a better job of testing ingredients and final products and to manage cross-contamination risks better. UK MHRA withdraws the GMP certificate for one Taiwanese API maker for its lack of knowledge of sterile processing. Meanwhile, FDA adds an Indian facility to its drug GMP import alert.
Manufacturing Compliance Updates In Brief
EU GMP noncompliance notice sent to Chongqing Succeway Pharmaceutical Co Ltd. for poor data integrity; FDA hits several firms in China and Mexico with drug GMP import alerts; Canadian maker of skin products warned for not testing active ingredients; FDA warns of death and adverse event stemming from intravenous infusions of curcumin compounded with polyethylene glycol (PEG) 40 castor oil.