Top Ten of 483 Findings by the FDA in Fiscal Year 2003

GMP News No. 408

19 April 2004

Top Ten of 483 Findingsby the FDA in Fiscal Year 2003

As a rule, it takes some time before the official FDA statistics for theprevious Fiscal Year are published.

However,the statistics for FY 2003 (October 2002 - October 2003) have already beenpublished at the GMP Conference held in Athens (Georgia, USA) from 15 to18 March 2004. Here, we would like to present you with some of the data.

In FY 2003, the FDA conducted 259 inspections abroad. 162 of them endedwith the issue of a "483." A 483 is a form on which the FDAinspector documents his or her inspection findings.

The frequency of complaints can also be analysed via the warningletters. Such a - very comprehensive - analysis is carried out every yearby CONCEPT HEIDELBERG. This may lead to a different order of findings,which is due to 2 reasons:

  • The FDA does not consider every finding as so critical or relevantthat it issues a warning letter (some of the findings are evendismissed!)
  • Depending on the analysis, the "deficiency groups" aredefined differently. A missing SOP for the validation of a waterfacility can e.g. either be classified as a "failure to follow and/or document writtenproduction and process control procedures" or as a deficiency in the"validation" category. However, this kind of deviation willbe less frequent in the future since recently issued warning lettersalways mention the CFR paragraph to which they refer.

For 2004, the FDA has planned to conduct 582 inspections, 210 of whichwith regard to "DrugQuality GMPs."

The FDA's analysis of the 483s is very informative, as these forms arenot available on the Internet. The analysis results in the followingclassification:

10th place "PRODUCTION RECORD REVIEW" (21 CFR 211.192):referenced on 141 of the 483 forms

9th place "COMPLAINT PROCEDURES are not established orfollowed" (21 CFR 198 (a)): referenced on 142 of the 483 forms

8th place "LABORATORY CONTROLS" (21 CFR 211.160 (b)): referencedon 163 of the 483 forms

7th place "PERSONNEL QUALIFICATIONS" (21 CFR.25 (a)): referencedon 166 of the 483 forms

6th place "VALIDATION" (21 CFR 211.110 (a)): referencedon 173 of the 483 forms

5th place "Failure to maintain complete and accurate BATCHPRODUCTION AND CONTROL RECORDS" (21 CFR 211.188): referenced on 178 of the 483 forms

4th place "TESTING AND RELEASE FOR DISTRIBUTION" (21 CFR211.165 (a)): referenced on 183 of the 483 forms

3rd place "WRITTEN PROCEDURES FOR PRODUCTION AND PROCESSCONTROLS" (21 CFR 211.100 (a)): referenced on 185 of the 483 forms

2nd place "RESPONSIBILITIES OF THE QUALITY CONTROL UNIT" (21CFR 211.22 (d)): referenced on 247 of the 483 forms

1st place "FAILURE TO FOLLOW AND/OR DOCUMENT WRITTEN PRODUCTION ANDPROCESS CONTROL PROCEDURES" (21 CFR 211.100 (b): referenced on 317 of the 483 forms

Sven Pommeranz


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