The U.S. House of Representatives Committee on Oversight and Government Reform recently published a 21 page staff report document that was highly critical of the FDA. Several of you had requested information regarding this report since you were interesting in reading the report that caused the FDA response. Enclosed below are several of the key … [Read more...]
FDA (CBER) ISSUES ELEVEN PAGE 483 TO SANOFI PASTEUR (04/25/11)
COMMENT CBER issued to Sanofi Pasteur an eleven page, 32 Observation Form FDA 483 following an audit of their Toronto, Canada facilities. The dates of inspection encompassed the time frame of April 10 - 25, 2012. CBER previously published the Warning Letter regarding this subject which was initially noted within this Blog earlier in the week. The most significant … [Read more...]
REGULATORY COMPLIANCE/EXPERT MICROBIOLOGICAL WITNESS CONSULTATION
Regulatory Compliance -- Form FDA 483/Warning Letters With the advent of only 15 calendar days to respond to regulators following a Form FDA 483 or Warning Letter, it is incumbent upon the recipients of these to use the time most productively to minimize any further regulatory actions. Understanding the Observation becomes the initial step. Unless the individuals are … [Read more...]
TOP POSTINGS FROM THE BLOG OF BARRY A FRIEDMAN, PHD
A RESPONSE TO YOUR QUERIES RE: FREQUENT TOPICS OF INTEREST Periodically, I am asked what are the most frequent topics which interest the reader. Because the reader has so many varied interests, it is difficult to determine this without retrospectively reviewing the data. I have summarized below the “top six” topics that have been viewed since the beginning of 2012. You may … [Read more...]
CURRENT CONTRACT MANUFACTURING OPERATION (CMO) REGULATORY ISSUES (3/15/12)
FEATURING A SUMMARY OF BEN VENUE ISSUES Policy changes and enforcement strategies implemented by the FDA have led to an increase in the number of inspection of both Contract Manufacturing Operations (CMOs) and in-house sterile manufacturers — especially injectables. There has been a greater oversight and detailed review of all protocols and processes. Any issue or potential … [Read more...]
