FDA Inspection -483 Form

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Rina
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FDA Inspection -483 Form

 
After inspecting a food, drug, medical device, or biologic establishment, FDA prepares a written report of its inspection findings, following a debriefing. This report is intended primarily for internal FDA use and is not provided to the inspected institution at the conclusion of the on-site visit. To provide the facility with its own written list of discrepancies noted during the inspection, FDA developed form FDA 483, “Notice of Inspectional Observations,” issued by the field investigator. Form 483 should contain only those observations that can be directly linked to a violation of regulations—not suggestions, guidance, or other comments. Although the 483 does not contain references to the regulations, each observation should be directly traceable to a section of the applicable regulations
(http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=92055)
 
Many consider receiving of a 483 Form as a slap on the wrist, however, an organization must take the observation serious.
 
It is important to list the observations individually and respond to each and every one by introducing the corrective action to each specific point. For the scientists/ students it may remind the answer to the referee(s) of the paper or thesis.   The main strategy is to show to the FDA how your organization intends on correcting the problem.
For more information and regulatory guidelines, please visit Investigations Operations Manual
http://www.fda.gov/ora/inspect_ref/iom/default.htm