The QMN Weekly Bulletin

Shortly after the FDA inspected Spinal USA’s facility and cited it for not having a quality system (QS) in place, the company retained a quality manager and implemented procedures to respond to the agency’s concerns, the firm said.

Higher energy costs are the primary reason for increased prices of active pharmaceutical ingredients (APIs) in China, not more oversight from regulators, according to Bao Yi of Beijing-based consulting firm JPT Consulting.

PRWT Services’ subsidiary Cherokee Pharmaceuticals has acquired a Riverside, Pa., plant from Merck.

Gov. Eliot Spitzer was in Rouses Point Tuesday to formally announce acquisition of the Wyeth Pharmaceuticals facility, which will save all 800 jobs.

Stryker Corp., which has operations in New Jersey, failed to correct manufacturing procedures that led to complaints about hip-replacement products, according to a report in The Record citing regulators.

Product recalls in the UK due to health and safety concerns have shot up to their highest level, with the rise in outsourcing to China fingerpointed for much of the blame.

Sartorius Stedim Biotech, which makes fermenters and other equipment for biotechnology and drug companies, will close its production facility in Bethlehem Township, Northampton County.

SAFC is still on its expansion drive with yet another multi-million dollar investment, this time at the company’s niche biologics plant in Carlsbad, California.

Medegen Inc., a leading provider of medical devices, components and manufacturing services to the healthcare industry, announced it has expanded its manufacturing capabilities into Tijuana, Mexico.