Beyond the Context of the Direct Observations – Preventing Future 483 Problems
A systemic response to any audit observations must equate to a systemic resolution to any issues within the firm. This action requires further evaluation than just actions in a system at a company site. The FDA in particular will require that all company sites implement corrective actions along the same plan of action.
Failure to do so may result in further regulatory actions. Programs need to be established which require any observations and the responses to be circulated for evaluation within a company to determine if other areas are non-compliant.
The following graph illustrates this approach.