5.5 FDA-483 Objectionable Conditions and Practices

Once an inspection is completed and before leaving the firm, an FDA-483 may be issued to the most responsible person at the site inspected. The FDA-483 itemizes all significant deviations from cGMPs. This may be prepared using TurboEIR, if applicable.  If this is the case, please refer to the TurboEIR section for additional guidance.

When writing 483s as an analyst, observations should be:

• Significant and correlate to regulated products or process inspected.
• Directly linked to a cGMP regulation for inspections using TurboEIR.
• Clear, accurate, and complete.
• Product names and lot numbers should be listed in the observation
• Listed in the order of significance.
• Legible if hand written.
• Related to the inspection.  For example, failure to adhere to application commitments is an FDA-483 observation.  However, product specifications are not a FDA-483 observation; and they should be discussed with the application Reviewer and addressed as a headquarters issue rather than a field issue.