The Indian government has developed new draft standard operating procedures for handling substandard drug samples. Source: Drug GMP Report

The owner and compliance director of Pharmakon Pharmaceuticals routinely sent drugs to hospitals without waiting for test results confirming the potency of the drugs matched their labels, and when results…

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. Source: Drug GMP Report

Persistent problems with quality will draw continued scrutiny and citations from the FDA, regardless of company size. Source: Drug GMP Report

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…

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…

A federal district judge shut down drugmaker Stratus Pharmaceuticals in Florida and distributor Sonar Products of New Jersey with a permanent injunction Thursday. Source: Drug GMP Report

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…

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 FDA hit multiple manufacturers with extensive Form 483s, including an Ohio outsourcing facility where failures to adhere to GMP and overall sterility, cleaning and quality control issues proved to…