Evaluation of Form 483 issued by FDA.
To evaluate the seriousness of a 483 and the potential for additional enforcement action, consider the following questions:
Is the 483 longer than 8-10 pages? Longer is not better. That doesn’t mean that a short 483 may not lead to serious enforcement actions, but a long 483 suggests problems may exist in many quality systems.
Do any of the observations have an extensive description of examples? I think any observation supported by more than 3 examples is one where the agency is trying to send a message about the breadth of the problem within the organization and may be an indication that additional enforcement actions are in store.
Do any of the observations state that they are repeat observations from previous inspections? This statement indicates that while the firm’s response to the previous inspection may have been acceptable, they didn’t implement effective/corrective/preventive actions to ensure a permanent ‘fix’ for the problem. This type of statement suggests that additional enforcement actions may be forthcoming.
Is the 483 issued to an executive? If so, it is yet another suggestion that the FDA is sending a message to the corporation regarding the seriousness of the inspection observations.
Do the areas addressed include lack of data integrity and poor aseptic practices with potential for contamination or cross-contamination? This combination of problems, particularly in the past few years, has frequently resulted in a warning letter or additional enforcement action.