Abbott 483 Notes Problem With Cleaning Procedure

October 13, 2010
Abbott Vascular was handed a Form 483 after an FDA investigator observed an assembler taking steps that could lead to the transfer of foreign particles from a waste container to a device. The assembler wiped a StarClose SE device with an alcohol wipe, then opened the lid of a waste container with her gloved hand to dispose of the wipe, despite the fact that the container had a foot pedal, and then continued work on the device without changing the glove, the Aug. 30 form says. The investigator observed the same event at least twice. Abbott has taken corrective action and has communicated its actions to the FDA, company spokesman Jonathon Hamilton said.
The GMP Letter