what is the meaning of 483 ?
483 is a FDA form. Read in detail -
An FDA Form 483 is issued to firm management
at the conclusion of an inspection when an investigator(s) has observed
any conditions that in their judgement may constitute violations of the
Food Drug and Cosmetic (FD&C) Act and related Acts.
These are the inspectional observation recorded by USFDA regulatory agencies. USFDA has Observation manangement system where all the findings are recorded under 483 and managed accordingly. To know more about the 483 and its management please refer http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm096015.htm
It is one of number …I.e List observations during FDA inspection.
In a very simple words, 483 is just a Form or Format, as we use any form or format of a SOP. USFDA always use the same terminology as it is referred in their federal regulations. For example 21 CFR, now one can ask what is 21 in 21 CFR.
Three terminology out of so many we usually hear from FDA is Form 483, Warning letter and EIR. Form 483 are usually filled during the audit which comprises of all the observations and discussion with management. It is the primary document FDA make for all future documents. For example: Upon discussion of all observations made on Form 483, site has to submit their response within 15 calendar days. if not found satisfactory FDA issues Warning letter. Its just a letter in usual letter format. and if everything is fine, FDA issues Establishment Inspection Report (EIR) which also contain the information captured in Form 483 and all the exhibits collected during the audit.
Hope its clear now
Thank you sir,I got it.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgement, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.