FDAnews
www.fdanews.com/articles/141363-capa-violations-cited-in-warning-letter-to-uk-devicemaker

CAPA Violations Cited in Warning Letter to UK Devicemaker

November 2, 2011
Devicemaker Rocket Medical failed to maintain adequate design controls and committed other good manufacturing practice violations, the FDA alleged in a warning letter. The firm was inspected July 11 through July 14.
Devices & Diagnostics Letter