Quality

FDA Hits Dr. Reddy’s With Warning for Repeat GMP, Data Integrity Issues

The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.” Read More

WHO Issues Global Data Integrity Draft Guidance

Good data integrity practices are drawing attention on a global scale, as the World Health Organization — with the help of international regulators — has released draft guidance that attempts to bridge gaps between the principles of good data and record management and actual practices. Read More

Guidance Allows FDA to Destroy Certain Drug Imports

The FDA has released a final guidance allowing it to destroy certain drug imports valued at $2,500 or less that have been refused admission into the country in an attempt to boost the integrity of the drug supply chain. Read More