Theqmnweeklybulletin

Feb. 17, 2017

Vol. 9 No. 7

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Zimmer Biomet Hit With 58-Page Form 483 Citing 14 Observations

Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Read More

FDA Reclassifies Influenza Test Systems as Class II

The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality of testing. Read More

Eisai 483 Handed Form 483 after Investigators Cite Control Records, CAPA Procedures

The FDA has served drug manufacturer Eisai Inc. with a Form 483 after an investigation revealed laboratory control issues and incomplete records. Read More

FDA Cuts Wait for Certain ANDA Approvals, Clears Up Misunderstandings on Reference Drugs

To help speed the approval of generics, the FDA said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Read More