Articles from Inspection Monitor (January 1, 1997)

Title	Author	Type	Words
Biomet 483 hits validation; FDA says it's not satisfied.		Brief Article	893
Ciba Vision avoids 483 despite validation slips.		Brief Article	309
Complaint, MDR concerns preceded TPS consent decree.		Brief Article	962
EIR Denials.		Brief Article	98
FDA rewrites strategy for design controls : Clinical study reference maintained.		Brief Article	189
FDA, Sera-Tec grapple over deferrals, inspection length.		Brief Article	602
INSPECTION LOG.			1517
IRBs cited on membership, SOPs, review, consent form.			1857
U. Michigan Blood Bank hit for testing, calibration.		Brief Article	370
Violations at select IRBs mirror FDA inspection data.		Brief Article	379