FDA Form 483 and warning letter

If you are working in a pharmaceutical industry which is exporting its drugs to the USA then you are familiar with the FDA Form 483 & warning letter.But if you are working in a pharmaceutical industry which is not dealing with the export of drugs to the USA then you must be familiar with the form 483 & FDA warning letter.

In this article you will learn about the form 483 & difference between form 483 & warning letter.

FDA form 483 vs warning letter

FDA Form 483

It is a routine practice for FDA investigators to inspect the manufacturing facility at specific time intervals or they may have a surprise on site inspection.

All the observations which are observed by the FDA officials during the on site inspection are noted on an official FDA document which is known as FDA form 483.Officially this form is known as ‘Notice of inspectional observations’.

The form 483 includes all the cGMP violations which may be related to the process, equipment, facility, testing, procedures or any activity which may impact the quality of the product.

It is not necessary that form 483 will only include the major violations rather it may also contain any simple & minor observation which according to the US FDA investigators must be addressed.

Purpose Of Form 483

The main purpose of the FDA form 483 is to intimate the management of the pharma company regarding the activities which are objectionable.Due to this this reason form 483 is always presented & discussed with the senior management of the organization.

How Form 483 Is Handed Over 

After completion of on site inspection the FDA investigators have a suitable period of time to write down the investigation report which is known as Establishment Inspection Report (EIR) & this report is submitted to the FDA headquarter.

The lead inspector of the FDA met with the firm management & handed the form 483 with complete discussion on each & every observation.

How To Respond Form 483

The organization after receiving the form 483 must take suitable measures to fix the violations mentioned by the FDA officials.The firm must respond to form 483 within the provided time frame with suitable corrective & preventive actions.

Examples of Form 483 Observation 

  • Data integrity problems.
  • Cleaning,sanitization or maintenance issues.
  • Environment monitoring issues.
  • SOPs & written procedures are not followed.
  • Non availability of written procedures.
  • Poor investigation of deviations.

What Is FDA Warning Letter 

FDA Warning Letter is the official document which is issued by the higher authority of the FDA to the manufacturers in response to severe regulatory violations.

Warning letter is issued if a pharma company failed to satisfy the FDA on the previous observations of the form 483.

Purpose Of Warning Letter 

The purpose of the warning letter is to notify the manufacturers to take prompt corrective actions against severe violation of FDA regulations.

How To Respond Warning Letter 

Warning letter is sent on priority basis including the detail of specific violation & after receiving the warning letter the manufacturer must send the response letter to FDA within the provided time frame.

The response letter must include the necessary measures & corrective actions taken for the regulatory violation.

Response Period For Form 483 & FDA Warning Letter 

The response period for form 483 & warning letter is 15 working days & this duration can be reduced for warning letters by the FDA depending upon the severity of the violations.

Difference In FDA Form 483 and Warning Letter 

To summarize, the basis difference between form 483 & FDA warning letter is as follows

  • Form 483 includes all the observations during on site inspection whereas a warning letter is issued on significant regulatory violation or not responding to the form 483 observations.
  • Form 483 & warning letters are sent to manufacture. A warning letter is published online on the FDA website as well.
  • No product recall or shut down of manufacturing activity is done in response to form 483 observations but can be implemented in response to a warning letter.
  • Form 483 is provided on site by the lead FDA investigator & warning letter is by the higher authority of FDA.

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