Responding to Observations

• Date: November 04, 2008

You have been through a rigorous FDA inspection, now what? You are handed a list of observations for which needs immediate corrective action. Responding to these observations is deemed Herculean task than facing the audit itself. The hows of responding to observations can be explained in steps as:

• Formation of committee
• Sub-committees to investigate particular committee
• Developing the response document
• Follow-up with FDA for its response on the document submitted
• Lessons learned

Its good to be compliant but companies need to look into the ground work that can make this a more productive and hassle free exercise by:

• Training its employees more frequently
• Upgrading the computer hardware to reduce on costs
• Better documentation and processes for efficiency