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
Labels: assessment, boston-scientific, critical-to-quality, fda, gmp, good-manufacturing-practices, guidant, healthcare, medical-manufacturing, quality-system
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posted by Frank M at 6:32 PM
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