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Inventia Healthcare, a drugmaker headquartered in Mumbai, India, was slapped with a Form 483 for serious violations at its Thane, Maharashtra facility, including poor data integrity. Read More
The FDA hit a drug manufacturer in Dresden, Germany with a warning letter for serious violations, including a lack of API and stability testing. Read More
The FDA hit a Tijuana drug manufacturer with a warning letter for shoddy investigations into microbiological contamination and other serious violations observed during an agency inspection. Read More
A majority of consumers and physicians believe generic drugs are inferior in quality to branded products, FDA officials said at a National Press Club event in Washington, D.C., yesterday. 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
The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers. Read More
An agency investigator found what appeared to be production in-process testing records, but the production supervisor “proceeded to grab the records from my hands,” the inspection report said. Read More