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…

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…

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

The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Source: Drug GMP Report

The FDA flagged facilities in Italy, India and China for noncompliances including inadequate testing, complaint handling, and quality data, among other violations. Source: Drug GMP Report

The FDA issued warning letters to eight drug manufacturers for adulterated products, misbranding and unapproved drug products, among other violations. Source: Drug GMP Report

Dr. Reddy’s agreed to pay $5 million to settle claims it sold products without sufficient safety testing of the packaging. Source: Drug GMP Report

ORA and CDER officials provided an update last month on the agency’s Concept of Operations initiative in a panel discussion at the FDLI Enforcement Litigation and Compliance Conference in Washington…