Articles from Inspection Monitor (July 1, 2007)

Title	Author	Type	Words
Adverse events noted in 483 for Purdue Pharma.			156
API firm written up for qualification, calibration and maintenance of equipment.			1021
Berkline cited for quality policy flaws in 12-item FDA write-up.			387
Device firm Seecor responds to 483 citing lack of SOPs for adverse events.			140
Forest Pharma nets 5-item 483 for faulty lab controls.			428
Inspection log.			239
Lordex written up for DHF and design controls in 3-item 483.			258
Mallinckrodt slapped with 3-item 483 for failing to review discrepancies and batch failures.			320
QA failures cited in 13-item 483 for DSM Pharma.			693
Shelhigh agrees to consent order; halts device distribution until GMP flaws are addressed.	Pickett, Joseph		1353