Guidant said last month it is on track to address the FDA’s warning letter concerns about a wide-range of Good Manufacturing Practice (GMP) issues including electronic records and signatures. Guidant “believes it can fully address the concerns of the FDA without a material impact to its business,” the company said in a Dec. 27, 2005, statement.
The company’s response came after a Dec. 22, 2005, FDA warning letter that told Guidant it had “failed to address all of the significant violations listed in the Form FDA-483.” Guidant has made monthly progress reports to the agency in an attempt to address the agency’s concerns. In its warning letter, the agency acknowledged Guidant’s letters of Sept. 15, Oct. 5, Oct.18, Nov. 17 and Dec. 15, 2005, which describe Guidant actions taken to address the observations and deviations cited by the FDA.
The FDA’s inspection focused on quality systems in Guidant’s Cardiac Rhythm Management (CRM) facilities in St. Paul, Minn. (PIR, Nov. 21, 2005, Page 1). While the correspondence between the FDA and Guidant does not directly mention Part 11, the 483 mentions software validation as referenced in Part 11, experts have told PIR.
To view the Warning Letter go to http://www.fda.gov/foi/warning_letters/g5657d.pdf.