Dealing with Obviously Serious Observations

If there is a significant and serious observation, remain calm and friendly as it could be that additional data could clarify the situation. Therefore, ask for a postponement of the question until you can provide further data. However, you should not do this to fend off the question, but with the intention to support the inspector as best you can and help him or her with the investigation of the facts. 

Use the gained time in the back office, involving all persons, who are able to contribute to the clarification and try to develop a conclusive answer. If you are unable to convince the inspector, please explain the circumstances on the basis of facts and mitigate the original observation by relativizing statements that are supported by facts. In practice, a three-step process for dealing with difficult observations has proved to be effective  

3) Describe procedures that will prevent such events in the future (CAPA or PAC A, sometimes it depends on the order of corrective and preventive measures). 

With the method described here, deficits can be dispelled, especially deficits found prior to the inspection by internal or third-party reviews and make them harmless for the FDA inspection. Experience reports that comprise a description of deficits, relativizing facts and appropriate CAPA are suitable tools to process the three-step method. 

If an observation is recorded on FDA Form 483, you have the opportunity to address and discuss this issue on each inspection day in the exit meeting. However, new data and additional information must be provided that was not available at the time, when the observation was made. Take advantage of the openness of the inspectors to discuss. Please keep in mind that for the inspectors the foreign environment and language are stressors and apply social and intercultural sensitivity in order to determine how far you can go in the discussion. 

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