St. Jude Medical’s Penang, Malaysia, plant received a seven-observation Form 483 at the conclusion of a May 2011 CDRH inspection.
The 483 cites multiple concerns with environmental control procedures followed in the facility’s cleanrooms. For example, dust had built up on cleanroom workbenches, and the facility manager in charge of cleaning the cleanrooms violated sterility by walking across a “non-clean” area in his shoe coverings before entering the cleanroom.
In addition, the 483 states employees in charge of assembly, packaging and quality control of Accent pacemakers and Tendril 2008 leads “are not adequately trained in the performance of their job functions.” The 483 also states that multiple processes for heart leads were not adequately validated because they could not be fully verified through subsequent testing.
The facility’s supplier control requirements were found inadequate because at least one crucial component was marked as “non-critical.” Management review procedures did not refer to supplier evaluation and assessments, the inspectors found.
“We have received the Establishment Inspection Report from the FDA indicating the 483 observations from the May 2011 FDA inspection of the Penang, Malaysia facility have been resolved,” St. Jude spokeswoman Amy Jo Meyer said. “A subsequent inspection at the Penang facility was performed in 2012 without a 483 being issued.”
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