A federal district judge shut down drugmaker Stratus Pharmaceuticals in Florida and distributor Sonar Products of New Jersey with a permanent injunction Thursday. Read More

Phillips Co. is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed after an FDA inspection found significant manufacturing practices that call into question “the safety, identity, strength, quality and purity” of unexpired drug products made at the firm in the past three years. Read More

The FDA plans to use its emerging technology program to help address key pharmaceutical quality and manufacturing challenges — and also train agency reviewers on the latest processes to keep pace with industry innovation. Read More

China’s Food and Drug Administration only carried out a fraction of the dozens of planned GMP inspections of foreign sites last year. Read More

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More

Quality issues and violations of FDA current good manufacturing practices are plaguing Hospira, triggering a series of recalls, contributing to a drug shortage and costing the drugmaker’s parent company a biosimilar license for a second time. Read More

A Texas-based compounder specializing in hormone therapies for men and women was warned by the FDA for extensive cGMP violations as well as producing drugs for which there was no valid prescription. Read More

The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More