Cordis Neurovascular Gets Two Citations

A month-long inspection led to two Form 483 observations for Johnson & Johnson subsidiary Cordis Neurovascular. The May 8 Form 483 cites the lack of a specific validation protocol associated with a new test method validation report at the Miami Lakes, Fla., manufacturing facility. The company also was cited for failure to conduct process controls in accordance with documented instructions and standard operating procedures. Both observations were corrected during the inspection, Christopher Allman, Cordis’ executive director of corporate communications, said.
The GMP Letter