Quality

Indiana Compounders Indicted on Conspiracy, Drug Quality

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 showed the strength was often nearly double what it should have been, covered up the error and lied to FDA investigators rather than notifying the FDA or customers, according to a 10-count federal indictment. Read More

Manufacturing, Safety Concerns Sparks Phillips Recall

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

OPQ Emerging Tech Program Aims to Improve Quality

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

SterRx Cited for Sterility Issues

The FDA cited a Plattsburgh, N.Y., outsourcing facility after an inspection in February and March found serious deficiencies in the company’s cleanliness and sterility practices. Read More