The FDA is improving its response times for generic drug applications, but facility inspections remain a major hang-up in the process, according to a GAO report. Read More

Persistent problems with quality will draw continued scrutiny and citations from the FDA, regardless of company size. Read More

The FDA broadened its import ban against Indian manufacturer Ipca Laboratories to include four drugs previously exempted due to shortage. The drugmaker’s continued GMP violations already kept most of the company’s products out of the U.S. market, but shortages led regulators to allow a handful of Ipca’s drugs into the country. Read More

Companies that are not keeping up with GMP cleanliness and sterility requirements are likely to get more than just a Form 483 from the FDA—they may get multiple visits from inspectors whose additional scrutiny could result in even more quality violations. Read More

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The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input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