FDA’S CDER SUMMARIZES TOP TEN 483 OBSERVATIONS AT PDA/FDA MEETING IN BALTIMORE (9/12)

COMMENT

Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s.  At this year’s PDA/FDA meetings which were held in Baltimore, MD, the FDA presented the totals calendar year to date.  The Observations within the top ten usually do not change — although their frequency may vary.  Where a specific section is indicated, the Title indicates the overall paragraph.  Please review 21 CFR Part 211 for additional specifics. 

TOP TEN CDER OBSERVATIONS FOR CALENDAR YEAR TO DATE (9/9/12) COURTESY OF PhD

SECTION  # OF              TITLE

211.22(d)       118  Responsibility of the Quality Control Unit

211.192            78  Production Record Review

211.100(a)       75  Written Procedures; Deviations

211.160(b)       69  Laboratory Controls, General Requirements

211.110(a)        63  Sampling and Testing of In-Process Materials  and Drug Products

211.67(b)         53  Equipment Cleaning and Maintenance

211.25(a)         46  Personnel Qualifications

211.100(b)       44  Written Procedures; Deviations

211.68(a)         44 Automatic, Mechanical, and Electronic Equipment

211.67(a)         44  Equipment Cleaning and Maintenance