RI Consultants Gets 483 for Weak Device History Record Procedures

RI Consultants, a maker of radiotherapy devices, was handed a Form 483 for a dearth of device history records and for not identifying the training needs of personnel at its Nashua, N.H., plant. FDA investigators determined RI lacked adequate procedures for device history records when they found a shipping slip that made no reference to a key radioactivity test, the May 11, 2011, form states.
The GMP Letter