Articles from Inspection Monitor (August 1, 2006)

Title	Author	Type	Words
23-item 483 handed to Allergy Labs for inadequate aseptic processing, sanitation procedures.			1369
Advent of QbD does not mean the end of process validation, industry says.	Pickett, Joseph		585
Andrx Pharma hit with 9-item 483 citing QC violations and control procedures.			1062
Device inspection reveals deviations from consent decree issued by FDA.			229
Device manufacturer comes up short on quality system, plans and audits.			481
Inspection log.			232
Lack of acceptance criteria nets 483 for American I.V.			525
Movement out of design space is a change that requires a regulatory post approval change process.	Pickett, Joseph		452
RA Medical hit with 6-item 483 for unfilled product report, faulty design plans.			765