Dec. 21, 2007 | Vol. 1 No. 26
The FDA has issued a final rule revising and clarifying its current manufacturing practice (cGMP) requirements for aseptic processing, water standards and the verification of production steps.
GE Healthcare has received its second warning letter in 2007, this time related to its diagnostic X-ray devices, just three weeks before it planned to notify the FDA that it was working to address manufacturing issues identified in a separate warning letter for its MRI coil and breast biopsy plate operations.
To avoid potential problems during FDA inspections, manufacturers should consider harmonizing their corporatewide policies with policies specific to individual manufacturing sites, according to a former FDA investigator.
After a recall left the Fridley firm with a gap in its product line there, regulators approved a pair of the insulated wires used with defibrillators.
Hyderabad-based pharma company Aurobindo Pharma, which has plans to emerge as a billion dollar company by 2009–10, is enhancing its presence in Europe by investing $100 million in phases.
A Johnson & Johnson plant that manufactures medical tools for knee and hip replacements at New Bedford Business Park has been sold for $45 million in cash to an Indiana-based provider of orthopedic products.
The 750 people who work at the Boston Scientific medical device plant learned their fate when the company announced the plant and related businesses would be sold to a New York City private equity firm for $425 million.
Indevus Pharmaceuticals has received a nonapprovable letter from the U.S. Food and Drug Administration relating to its drug Valstar.
Physio-Control, the company that makes Lifepak brand defibrillators, confirmed that it is on track to resume full shipments by April 30 and that it is making progress toward improving previously reported problems.
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