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Two drug compounders found themselves caught up in FDA’s increased focus on drug compounding when they were slapped with warning letters for the production of adulterated drugs and for sterility concerns. 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
The FDA hit Kolmar Korea with a Form 483 over numerous violations — including negligent handling of documents, lack of employee training and failure to conduct process validation — after a September inspection of its Sejong City, South Korea facility. Read More
The FDA issued Malladi Drugs & Pharmaceuticals a warning letter for significant good manufacturing practice failures at an active pharmaceutical ingredient facility in Tamil Nadu. Read More
The FDA warned a drugmaker in the Dominican Republic for significant good manufacturing practice violations including maintaining incomplete test data and faulty analytical methods. Read More
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection. Read More
The FDA issued Malladi Drugs & Pharmaceuticals a warning letter for significant good manufacturing practice failures at an active pharmaceutical ingredient facility in Tamil Nadu. Read More