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As part of its heightened focus on data integrity the FDA has increased the sophistication of its inspections to identify hard-to-find data violations, according to a former CDER official who shared data integrity compliance tips in an FDAnews webinar. Read More
The FDA issued Dr. Reddy’s a Form 483 after an inspection of its Medak, Telengana facility in India determined it did not establish quality agreements with material suppliers and failed to complete multiple CAPAs in a timely manner, among other violations. Read More
The European Medicines Agency is seeking public comments on a new template for GMP non-compliance statements, specifically in cases where a manufacturing site’s failed inspection could lead to shortages of critical medicines. Read More
The FDA issued Dr. Reddy’s a Form 483 after an inspection of its Medak, Telengana facility in India determined it did not establish quality agreements with material suppliers and failed to complete multiple CAPAs in a timely manner, among other violations. Read More
An FDA inspection of drugmaker Goran Pharma in November netted the company a Form 483 with 17 observations ranging from inadequate employee training to laboratory deficiencies and contamination risks. Read More