CDER NAMES THESE TEN (21 CFR 211)
The following represent those most frequent Observations that CDER posted for fiscal year 2010 based on a total of 646 FDA Form 483.
|
REFERENCE |
FREQUENCY |
SHORT DESCRIPTION |
|
211.22(d) |
149 |
Procedures not in writing, fully followed |
|
211.100(b) |
104 |
SOPs not followed/documented |
|
211.192 |
98 |
Investigations of discrepancies, failures |
|
211.160(b) |
83 |
Scientifically sound laboratory controls |
|
211.110(a) |
82 |
Control procedures to monitor and validate performance |
|
211.100(a) |
81 |
Absence of written procedures |
|
211.167(b) |
71 |
Written procedures not established/followed |
|
211.25(a) |
66 |
Training-operations, GMPs, written procedures |
|
211.67(a) |
61 |
Cleaning/sanitizing/maintenance |
|
211.68(a) |
60 |
Calibration/inspection/checking not done |
