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| Data Integrity App |
POST inspection
If FDA Issues a FORM
483, Prepare a Written Response:
During the exit interview, the FDA Investigators will likely
present their observations, findings and conclusions. In most cases, any
regulatory or food safety violations will be documented in an FDA FORM 483.
Although a response is not required by law, a company is
generally expected to provide a written response within 15 business days. If
the written response adequately addresses FDA’s concerns, FDA will not pursue
further regulatory action.
If the response is inadequate, however, the agency may issue
a “Warning Letter” threatening to withdraw the company’s registration and
prevent it from producing product.
Form 483’s written response should include
The written response should include specifics:
- Was the finding an
oversight/one-time occurrence or systematic
- What corrective actions will be
taken and why the proposed response will correct the issue.
- Provide a reasonable timeline for
the correction
- If the quality head is in
disagreement with an observation, respond with facts and verifiable
evidence.
- Address each particular observation
or finding, point by point.
- The reply should be sent within two
weeks.
- Maintain a copy of the final
signed responsein your office
If a 483 is issued, make a written response by including the
specifics.
Support Your Written Response with Documentation:
When FDA issues a FORM 483 or “Warning Letter,” make sure
your response is appropriately supported with adequate documentation.
For instance, FDA
will not be satisfied if you simply state in your response that you corrected a
problem that the FDA Investigators observed by “conducting additional employee
training.”
Rather, in addition to stating that you completed the
training, FDA will expect you to attach a training log or other document to
your response which provides evidencing that the training was, in fact,
completed.
If FDA Suggests a
Recall, Consult Your FDA Counsel:
Sometimes the FDA Investigators will observe conditions they believe warrant a recall. The decision whether to announce a recall in the first instance, and any determinations regarding the scope of any such recall, can vary greatly depending upon the facts and data.
Any recall decisions should
thus be made very carefully, and only after consultation with an experienced
FDA compliance attorney. Many companies have successfully convinced FDA, based
upon the availability of supporting facts, forensic analysis and scientific
data, that the agency is incorrect and a recall is not needed, or the scope can
be significantly limited.
“Trust but Verify “ Ronald Reagan
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| Data Integrity App |
Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.
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