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A second FDA inspection of niche drugmaker Sri Krishna in almost 10 years has turned up a bevy of complaints regarding the company’s quality control systems and the accuracy of its data. Read More
Spain’s Agency of Medicines and Medical Devices has suspended the manufacturing authorization for finished processing of Madrid-based Inmunotek over GMP deficiencies. Read More
In the latest of a string of manufacturing snafus plaguing Indian drugmakers, the French National Agency for Medicines and Health Products Safety is calling for the withdrawal of Anuh Pharma’s GMP certificate. Read More
France’s National Agency for Medicines and Health Products Safety has ordered vaccine maker Theravectys to halt production at its Villejuif plant for seven months after finding numerous GMP deficiencies. Read More
The FDA is continuing its crackdown on Chinese drugmakers, adding three more companies this week to its import alert lists over faulty GMP practices and a refusal for inspection. Read More
In response to a slew of warning letters regarding data integrity issues, the FDA is addressing questions on the matter that have come up in recent inspections. Read More
The fragmented nature of the modern manufacturing sector necessitates focusing less on technology and more on integration, according to an industry expert. Read More
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after apparently finding numerous GMP deficiencies. Read More