The Food and Drug Administration (FDA) notifies companies identified as having objectionable conditions with its form 483. This is presented to the company and discussed in an effort to remedy the situation. The FDA encourages companies to respond to this form in writing.
Instructions
Understanding the 483
1. Obtain a copy of your 483 from the FDA agent. An official copy will only be issued at the end of the discussion of the form, although drafts of the form can be seen before this point.
2. Verify that all information is correct, including the name and title of the individual to whom the report is issued, the date(s) of inspection, addreses, contact information, and signatures of affected employees.
3. Read the observations. This section will begin with "During an inspection of your firm I/we observed ..." and will list the objectionable conditions found in your company. Discuss with the FDA agent any phrases or words that are ambiguous or unclear.
Responding to the 483
4. Formulate a corrective action plan that includes steps to remedy or rectify any problems listed under "Observations" on the FDA 483. Confirm with senior managers that all actions are reasonable and possible. These remedies should allow the conditions to be righted quickly.
5. Type the corrective action plan. Be clear and succinct, and avoid unnecessarily ambiguous language. Organize your plan according to the observations made in the 483, and address each observation separately.
6. Sign your corrective action plan and mail it to the FDA agent responsible for issuing the 483, keeping a copy on file for yourself.
7. Implement the corrective action plan expeditiously.
Tags: action plan, corrective action, corrective action plan, objectionable conditions