We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Therapiva Private, an active pharmaceutical ingredient manufacturer in India, was hit with a Form 483 by the FDA for quality control unit and cleaning lapses. 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
The FDA has issued Form 483 inspection reports to seven drug companies for a variety of GMP and other lapses, including problems with data integrity, complaint handling and visual examinations of finished drug products. Read More
Four U.S. drugmakers drew FDA warning letters for violations ranging from the use of contaminated water to the promotion of unapproved drug products. Read More