The QMN Weekly Bulletin

A bevvy of concerns about complaint handling and inventory led to an FDA warning letter for wheelchair-lift maker ThyssenKrupp Access Manufacturing.

Amid ongoing efforts to address a previous FDA warning, Impax Laboratories has been hit with a fresh Form 483 after a general inspection unearthed additional quality issues at the company’s Hayward, Calif., facility, further complicating a growing ANDA backlog, the drugmaker says.

Sponsors and contract research organizations will craft trial contracts that are entirely in their favor, but that doesn’t mean sites are tied to this proposal verbatim, a site expert says.

Sen. Sherrod Brown (D-Ohio) had harsh criticism for FDA Commissioner Margaret Hamburg recently, questioning the agency’s lack of enforcement actions against companies’ with holes in their supply chain knowledge.

China’s State Food and Drug Administration (SFDA) has launched a four-month nationwide field program aimed at routing out businesses that provide inferior and counterfeit drugs.

Infimed, a maker of software and specialized hardware for medical imaging, does not always review all acceptance records and packaging checklists before releasing product for shipment, a Form 483 for the company’s Liverpool, N.Y., plant states.

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device have earned the German company an FDA warning letter.

Hospira continues to shell out money to fix quality issues at its manufacturing plants, costing the company a nearly 73 percent decrease in its earnings per share for the first quarter of 2012.