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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
The FDA’s warning letters for 2019 once again targeted many familiar GMP failures, such as quality units that either lacked or failed to follow written procedures. Read More