Category Archives: Drug GMP Report

The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts.
Source: Drug GMP Report

The FDA cited five drugmakers for problems relating to training, unsanitary conditions, document handling and other deficiencies.
Source: Drug GMP Report

The FDA issued warnings to three overseas and two U.S. facilities for a variety of nonconformances including inadequate testing.
Source: Drug GMP Report

The House passed an omnibus spending bill on March 22 that boosts FDA funding for medical product safety activities by $113.2 million, including a one-time payment of $94 million to expand FDA’s surveillance efforts at international mail facilities to address the opioid crisis.
Source: Drug GMP Report

Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC).
Source: Drug GMP Report

Four firms in Switzerland, the United Kingdom and the U.S. were hit with Form 483s for having inadequate cleaning and sanitization procedures, in addition to batch record issues.
Source: Drug GMP Report

The FDA warned five firms in South Korea, China and Germany for various GMP violations, including problems with sanitation, facility procedures and complaint handling.
Source: Drug GMP Report

In Jan. 30 testimony before a House subcommittee, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk.
Source: Drug GMP Report

The FDA issued Form 483 reports to facilities in Germany, China, Mexico, South Korea, the United Kingdom and the U.S. for a range of nonconformance issues.
Source: Drug GMP Report

The FDA cited issued warnings letter to drugmakers in Japan, Mexico, Australia and to three in the United States for GMP and other deficiencies.
Source: Drug GMP Report