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Articles from Inspection Monitor (November 1, 1997)

1-12 out of 12 article(s)
Title Author Type Words
Back-to-back inspections show site-to-site variability. Brief Article 607
Blood bank outdoes rules, gets praise instead of 483. Brief Article 355
First audit of EBI plant leads to warning letter. Brief Article 838
Five years of audits show ups and downs at Lifecore. Brief Article 793
INSPECTION LOG. Brief Article 796
Merck, FDA debate sales prior to NDA supplement. Brief Article 913
Miscommunication seen marring validation review. Brief Article 388
More second-guessing seen on product changes : Primarily in biologics, also devices. Brief Article 621
Notice of inspection fails to help Bartels avoid 483. Brief Article 714
PML survives 5-year gap in audits with no big slips. Brief Article 480
Post-approval, field alert audits spare Lederle 483s. Brief Article 388
Re-formed company cited on GMPs after conviction. 1108

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