IS A WARNING LETTER FORTHCOMING? A Pharmacia Upjohn subsidiary of Pfizer (Kalamazoo, MI) received a FDA Form 483 following an inspection from June 23 through July 9, 2015. This eight Observation 483 covered both non-sterile and aseptic issues. This audit used the Agency’s recently introduced team-based inspection approach and included Thomas Cosgrove, … [Read more...]
Quality Metrics and Risk Based Inspections
FDA’s Request for Quality Metrics (New Proposed Guidance July 2015) and Its Basis – The FDA’s Safety and Innovation Act (FDASIA) A Live, Interactive Training Webinar; See: http://www.tungstenshield.com/barry-a-friedman-phd/ Date: Tuesday August 18, 2015 Time: 9:30 - 11:30 AM ET (New York Time) Instructor: Barry … [Read more...]
FDA’s CDER LISTING OF TOP NINETEEN OBSERVATIONS FOR 2014
TOP FOUR OBSERVATIONS REMAIN SIMILAR IN NUMBER TO 2013 Each fiscal year the FDA issues the various FDA 483 Observations from the various Centers to include CBER, CDER, CDRH, etc. This Blog focuses only upon those issued by the Center for Drug Evaluation and Research (CDER) and will concentrate upon those found within 21 CFR Part 211. Interestingly, … [Read more...]
2015 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program
7-Part Live Training Program Starts September 30, 2015 Instructor: Barry A. Friedman Ph.D. The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been … [Read more...]
ZHEJIANG JIUZHOU PHARMACEUTICAL CO. RECEIVES IMPORT ALERT (3/18/14)
FDA PROVIDES NO RATIONALE FOR ALERT After the Warning Letter for Zhejiang Jiuzhou Pharmaceutical Co. was published in a recent Blog (8/20/14), several of my colleagues sent me comments regarding this Chinese Active Pharmaceutical Ingredient (API) source. They were particularly intrigued by the Blog because one had observed an Import Alert that was issued by the FDA on March … [Read more...]
