Boston Scientific Manufacturing Process Change Impact

Boston Scientific, manufacturer of medical devices, experiences business impact from process changes in manufacturing. ...

... "manufacturing process changes to two of its products have not yet been approved by the Food and Drug Administration, and it would stop shipment on those items until the problem is resolved. " ...

Via Forbes: Boston Scientific

Quality System Improvement: Medical Manufacturing Practices R Critical

Quality system improvements put Guidant manufacturing back on track. An FDA audit cited 483 observations that required remediation. This prompted Guidant to perform a thorough and systemic review of its quality system. ...

... "The FDA re-inspected Guidant's cardiac rhythm management (CRM) facility in St. Paul, Minnesota between November 9 and December 7, 2006. The re-inspection included an assessment of Boston Scientific's implementation of quality system improvements in response to the warning letter. FDA inspectors noted no observations during the re-inspection. " ...

Via Boston Scientific: Boston Scientific Resolves CRM Warning Letter Deficiencies