The QMN Weekly Bulletin

The FDA is still dissatisfied with Hospira’s Rocky Mount, N.C., facility following a 2010 warning letter, despite its efforts to correct FDA-cited deficiencies, the company said in a special investor’s call.

Rebuilder Medical has been repeatedly remiss in responding to customer complaints and has not established a management review process during its 10-year history, a Form 483 states.

By pushing inspector training and reemphasizing a directive that investigators focus during inspections on two facility systems, the U.S. Food and Drug Administration (FDA) hopes to do a better job of inspecting device and other facilities.

File this under “from bad to worse.” Having contributed significantly to the scandalous prescription drug shortage, Hospira may be on track to get hit with a consent decree by the FDA, according to one Wall Street analyst, who believes its ongoing manufacturing problems are much worse than anyone previously thought.

Next Generation Pharmaceutical Manufacturing Europe will take place from Dec. 6-8 in Barcelona and will provide leading executives with an ideal framework for new business relationships to flourish.

Dalton Pharma announced the company has received “Compliant” rating from Health Canada following the completion of the regulatory agency’s Good Manufacturing Practices inspection of the facility.

Dalton Pharma announced the company has received “Compliant” rating from Health Canada following the completion of the regulatory agency’s Good Manufacturing Practices inspection of the facility.

Israeli generic drug maker Teva will soon complete construction of a new production hall at its plant in Godollo, just outside Budapest.

A study that has been undertaken to weigh the pros and cons of seeking a new buyer for a local pharmaceutical plant is nearly half complete.