The FDA has released a warning letter to Guidant, criticizing the company's quality assurance procedures at its St. Paul, Minn. facility.
According to the recent letter, the facility fails to conform to current good manufacturing practice requirements for devices. Among the facility's violations are its failures to validate the sufficiency of its manufacturing processes, provide adequate procedures to address changes to these processes, and have adequate procedures to address nonconformance and other quality problems.
The letter called on Guidant to "promptly initiate permanent corrective and preventive action on your quality system." In the meantime, the agency will not approve pre-market applications or grant that facility the authority to export its products until its concerns have been addressed.
The FDA also warned Guidant that if these problems are not addressed the agency may take regulatory or legal action, including seizure, injunction and/or civil monetary penalties.
The letter is available at http://www.fda.gov/foi/warning_letters/g5657d.pdf (http://www.fda.gov/foi/warning_letters/g5657d.pdf).
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