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Compliance Recovery Zone
Have you been cited? Follow these "Tips for a Speedy Recovery" when you get an FDA 483 citation or Warning Letter for uncorrected 483s:
1. Respond quickly in writing—do not miss the deadline!
If your response arrives afterward, there will be consequences.
2. Assemble your team immediately!
Include:
a) Observation area personnel
b) Quality assurance
c) Regulatory affairs
d) Legal staff
e) A documentarian
f) One person to keep process on track
3. Delegate FDA observations to staff with direct responsibility.
Prepare a tracking document with the following information:
a) The observation
b) Name of responsible individual
c) Word-for-word response given to FDA
d) Root cause
e) Corrections (if any)
f) Corrective actions
g) Preventive actions
h) Completion due date(s)
i) Effectiveness
4. Get experienced outside help.
It’s often hard to convince the FDA that the organization responsible will solve an issue effectively by itself.
5. Respond with plans for:
a) How you will correct the problem
b) How you will prevent the problem in the future
6. Do not overcommit.
Be sure that what you promise to do is achievable and realistic.
7. Be prepared to provide objective evidence.
Be prepared to prove that you did what you said you would do (see Number 3).
8. Assemble the proof book with all primary documentation.
To show to the FDA when they return, proof book should contain:
a) A copy of the FDA citation
b) A copy of the response numbered consecutively, actions highlighted/tabbed
c) Objective evidence in each tab (i.e., protocols, procedural changes, training, decisions, action plans, and proof of task completion)
9. Assemble proof support book with all secondary documentation.
Include documents that might be referenced in objective evidence documents, tabbed to match the proof book.
10. Build FDA relationships in advance.
a) Be proactive
b) If there is a problem for their attention, call them to explain before they call you
c) Have direct, frequent involvement of senior management to avoid perception of disinterest, lack of seriousness
d) Don’t be adversarial
e) Let the agency know there’s a problem and you are
correcting it
ABOVE ALL, DON’T PANIC. HELP IS A PHONE CALL AWAY!
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