A lot of pharmaceutical professionals have confusion between FDA Form 483 and Warning Letters. Both of these are issued by Food and Drug Administration (FDA) after a regulatory inspection of the manufacturing facility and both are the way of communication.
FDA Form 483: Form 483 is used by the FDA to communicate the inspection observations. All observations are listed in descending order of their importance.
Form 483 is issued at the manufacturing site after the completion of the FDA audit. In other words, FDA officials communicate their inspection observations on Form 483.
Handling the FDA Form 483:
● At the time of conclusion on inspection, findings should be discussed with the inspector and try to resolve the negative observations before the inspector leaves the site.
● Consult the errors and miscommunications with the inspectors
● Try to understand the message sent by the regulatory agency i.e. their positive or negative mood.
● Ask the questions regarding confusions found in the observations.
● Try to convince the inspector on observation with more related information on the observation. It may help to delete the observation from Form 483.
● Respond the FDA Form 483 within the 15 days otherwise regulatory agency will not consider it during the decision of the company.
● A good response to the FDA Form 483 may avoid the issuance of a Warning Letter.
Related: Self Inspection and Quality Audits
Warning Letter: After the issuance of FDA Form 483 and completion of the inspection, a regulatory agency may issue a Warning Letter to the manufacturing site. When any serious issue is found regarding the quality of the product, a Warning Letter is issued by the higher officials of FDA after the review of the inspection observations. It contains evidence and detailed explanations for the observations.
A Warning Letter should be replied within the given time because delay can lead to the import ban. It may be asked for an extension of the time to justify the things.
Generally, FDA concentrates on the quality of the product and does not compromise with the product quality. Most of the Warning Letter issued by FDA has the quality or cGMP issues.
Both FDA Form 483 and Warning Letters are public notifications and these can be viewed on the FDA’s website because these are published immediately publically on fda.gov.
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