Understand Your FDA 483 Observations
Your best approach is avoiding a FDA Warning Letter by appropriately responding to the FDA 483 observations. It is essential that the FDA observations be understood and evaluated in the context in which they were given. Personnel involved with the audit should have input into the reasoning behind the issue. Hopefully, the auditor will provide feedback either when the observation was made or on a daily basis. This is an opportunity to understand the point being made. Typically, the last prospect for obtaining feedback directly from an auditor is during the close-out meeting.
FDA Close-Out Meeting
The close-out meeting is a review of the observations made by the auditor. For the US FDA, if a Form 483 is issued, the firm will receive it during this close-out. For internal, corporate or external auditors, there is usually a verbal close-out meeting followed shortly thereafter with a formal report.
During the close-out meeting (especially during formal or governmental audits), it is important to have the appropriate personnel in attendance. These people usually represent Quality Assurance, Regulatory Affairs, Operations and a member of senior management. It is important to keep the number of personnel in attendance to a reasonable level. Too many people and the auditor may become uncomfortable. Too few, it may seem that you are not taking the audit seriously.
Decide in advance how you are going to approach the close-out meeting. Will you question every observation and attempt to get them removed – analogous to a “Scorched Earth Policy”? Will you accept every observation even if there are errors present? Who will comment on the observations – everyone? Will people debate or disagree with valid observations?
A good approach is typically one that abides by the following outline:
There are other means of gaining an understanding of the FDA 483 observations, including, but not limited to, obtaining the EIR (Establishment Inspection Report) or contacting the inspector directly for questions. If, however, things are bad…and you get the Warning Letter…
Next – Your FDA 483 Response
Free FDA 483 Action Package
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