Food & Drug Inspection Monitor: Analysis of FDA 483s & EIRsfor Drugs, Devices & Biologies

摘要

Specia/ Report: Surviving FDA GMP Inspections; Human Drugs: Able Laboratories, Cranbury, NJ; Medical Devices: Two Rivers LLC, Tazewell, TN; Medical Devices/Biologies: Medsep Corp., Covina, CA; 483/EIR Update: Inspection Log; FDA to move ahead with itsown QS guidance despite overlap with ICH Q10 initiative: CHICAGO — FDA is moving forward with its own guidance document on quality systems for drug and biologic manufacturing facilities despite the recognition it may overlap with a similar International Conference on Harmonization (ICH) document, officials told a meeting here July 14.