Form 483 and Warning letters

The Perspective of FDA(Food and drug administration) In issuing the Form 483 and Warning letters is to guide the organisation that violation of  21 CFR(code of federal regulations) / cGMP (current good manufacturing practices) is occurring in premises and should be rectified immediately with effective corrective and preventive action .

Almost every pharmaceutical professional is aware of 483 it is an form issued by FDA officials citing the findings in an audit .

Auditing the premises is a way in which the regulatory agencies confirms  safety and efficacy of food and drug products and Form 483 is associated with FDA

Although FDA have jurisdiction in USA only but  boundaries exists far beyond as in case of pharmaceuticals many other countries are exporting drugs to USA the FDA gives power to its officials to inspect the pharmaceuticals exporting  drugs to USA and in case of serious violations it may lead to import ban from FDA .

Form 483 is a list of the observations which  FDA officials have observed during inspection of pharmaceutical organisation .observation with highest importance will be on top followed by lesser important issue .

In general form 483 is full of errors as these are only observations . It may not have any link with violation of law

Warning letters FDA(Food and drug administration)

Warning letters is a definite problem warning letter means the Form 483 have been through the senior FDA officials and serious violations of 21 CFR(Code of federal regulation) have been observed . and the corrective and preventive actions to an observations should be submitted within 15 days by the pharmaceutical organisation or the consequences could be an Import ban.