FDA CDER Most Frequent Form FDA 483 Observations Fiscal Year 2012

COMMENT

Each year CDER summarizes the number of significant Observations obtained from Form FDA 483s.  Enclosed are the “top fifteen” Observations.  The Observations within the top fifteen usually do not change — although their frequency and ranking may vary. Please note that the frequencies of various Observations have markedly increased in FY 2012.  Where a specific section is indicated, the Reference Number indicates the overall paragraph. You may wish to review this list with your own facility operations.  Please review 21 CFR Part 211 for additional specifics. 

Ref No Freq Short Description

21   CFR 211.22(d)

169

Procedures not in writing, fully followed

21   CFR 211.192

119

Investigations of discrepancies, failures

21   CFR 211.100(a)

116

Absence of Written Procedures

21   CFR 211.160(b)

115

Scientifically sound laboratory controls

21   CFR 211.110(a)

89

Control procedures to monitor and validate performance

21   CFR 211.67(b)

73

Written procedures not established/followed

21   CFR 211.68(a)

69

Calibration/Inspection/Checking   not done

21   CFR 211.25(a)

65

Training–operations, GMPs, written procedures

21   CFR 211.67(a)

65

Cleaning/Sanitizing/ Maintenance

21   CFR 211.100(b)

64

SOPs not followed/documented

21   CFR 211.165(a)

62

Testing and release for distribution

21   CFR 211.188

56

Prepared for each batch, include complete information

21   CFR 211.25(a)

54

GMP Training Frequency

21   CFR 211.63

54

Equipment Design, Size and Location

21   CFR 211.113(b)

47

Procedures for sterile drug products

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About Barry A. Friedman, PhD LLC

Regulatory Compliance, Expert Witness, Pharmaceuticals, Biotechnology, Aseptic Processing, GMP, GLP, Quality Control, Positron Emission Tomography (PET), Microbiology, Process Validation, Validation of Analytical and Microbiological Methods
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