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

However, the statistics for FY 2003 (October 2002 - October 2003) have already been published at the GMP Conference held in Athens (Georgia, USA) from 15 to 18 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 ended with the issue of a "483." A 483 is a form on which the FDA inspector documents his or her inspection findings.

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

1. The FDA does not consider every finding as so critical or relevant that it issues a warning letter (some of the findings are even dismissed!)
2. Depending on the analysis, the "deficiency groups" are defined differently. A missing SOP for the validation of a water facility can e.g. either be classified as a "failure to follow and/or document written production and process control procedures" or as a deficiency in the "validation" category. However, this kind of deviation will be less frequent in the future since recently issued warning letters always mention the CFR paragraph to which they refer.

For 2004, the FDA has planned to conduct 582 inspections, 210 of which with regard to "Drug Quality GMPs."

The FDA's analysis of the 483s is very informative, as these forms are not available on the Internet. The analysis results in the following classification:

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

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

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

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

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

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

4th place "TESTING AND RELEASE FOR DISTRIBUTION" (21 CFR 211.165 (a)): referenced on 183 of the 483 forms

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

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

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