Articles from Inspection Monitor (June 1, 1998)

Title	Author	Type	Words
ALP gets two 483s from GMP/preapproval audit.		Brief Article	948
Design control rules unknown at lens firm.		Brief Article	405
Design controls a breeze, COMSTAT bothers Luther.			800
Findings conflict with ex-employee's charges.		Brief Article	356
Granutec turnaround seen after warning letter.		Brief Article	790
Hybritech aces QS, design control audit.		Brief Article	342
Inova visit mixes design, manufacture, blood rules.		Brief Article	729
INSPECTION LOG.		Brief Article	597
Lack of clinical batch shifts preapproval audit.		Brief Article	555
Naval blood bank issues unsure units, shuts down.		Brief Article	1193
QS rule, design controls are news to small firm.		Brief Article	299
Regulators split over out-of-spec test results : No FDA guidance seen, except GMPs.		Brief Article	746
Software firm gets by with no design controls.		Brief Article	193
Two-man operation receives five-item 483.		Brief Article	345