FDA Presents Its Analysis of Observations Noted on 483 Forms

GMP News No. 321

GMP News
18 June 2003

FDAPresents Its Analysis
of Observations Noted on 483 Forms

It usually takes some time before one canaccess the official FDA statistics for the previous fiscal year (October2001 - October 2002).

This has indeed happened only recently,so that we can present you with a current selection of data. 

In Fiscal Year 2002, the FDA conducted 281 inspections abroad. 185 ofthem ended up with the issuing of a 483. The analysis of the 483s isvery interesting since they themselves cannot be viewed on the Internet.

The topical focus of the 483s already follows the structure of FDA'snew System-based Inspections. Most of the observations refer tofacilities/equipment, laboratory (21% each) and the quality system (20%).Production (18%) ranks 4th. The material system (12%) andpackaging/labelling (5%) rank 5th and 6th respectively.

All systems

Illustration 1

35% of the 477 observations made in laboratories were of a generalnature. Inadequate records/SOPs rank 2nd with 27% and the stabilityprogramme ranks 3rd with 21% (cp. illustration 2).

Laboratory system

Illustration 2

466 observations noted on a 483 referred to the facilities/equipmentsystem. In this area, the worst offender was cleaning/maintenance with28%, closely followed by inadequate records/SOPs (25%), which rank 2ndagain. Equipment design/qualifications ranks 3rd with 17%. Seeillustration 3 for further details.

Facilities/equipment system

Illustration 3

450 observations concern the quality system. 30% of them find faultwith the documentation, 28% disapprove of the QA conduct, and 25%criticise the failure investigation/OOS. What is interesting is the factthat these data only encompass the period from February to July 2002 (seeillustration 4)!

Quality system


Among the 394 observations regarding the productions system, inadequatedocumentation is again in the lead (39%). Process/design validation (24%)ranks 2nd and product/process control (21%) ranks 3rd. For further detailssee illustration 5.

Production system


As many as 42% of the 294 observations regarding the material systemcensure the components/closure integrity. Inadequate records/SOPs come 2ndwith 21% and process water, 3rd with 17% (cp. illustration 6).

Material system


The last system (packaging and labelling) gave rise to 104observations. Process and controls was referenced in 47% of theseobservations, which is the highest percentage of all systems. Inadequaterecords/SOPs (36%) and training/qualification (17%) rank 2nd and 3rdrespectively (see illustration 7).

Packaging/labelling system


These 483 findings are correspondingly reflected in the analysis offindings in Warning Letters (cp. GMPNews of 2 April 2003).

Sven Pommeranz


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