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FDA 483 and Warning Letter

For the purpose of protecting public health and ensures compliance with the Food, Drug and Cosmetic Act, Food and Drug Administration (FDA) conducts inspections of manufacturing facilities that manufacture, process or pack the products and analytical testing laboratories that analyse/test the product or raw materials used in the drug products including clinical research organizations (CRO) that performs the clinical trials or bio-equivalence studies.

What is FDA Form 483?

At the conclusion of the inspection, FDA inspector issued a list of observations made during the inspection in FDA’s Form no.483 which is generally called as 483’s.

 

What is Warning letter?

After a Form 483 is issued and the inspector completes the Establishment Inspection Report, FDA give chance to that firm to give response to 483 observations issued and to explain the corrective and preventive actions taken by the firm.

If FDA finds that the response to 483 observations are not satisfactory and if there is a significant violation of the regulations, Agency (US FDA) may issue a warning letter to the firm, based on the on the nature of the violation.

What next to Warning Letter?

Further if these significant violations not corrected promptly and satisfactorily, FDA initiates an enforcement action to that firm including Consent Decree.

What is the difference?

483 are the observations given by the FDA Inspector as a result of inspection while warning letters issued when FDA finds significant violation of the regulations.

What FDA Expects?

FDA expectation to give the warning letter is to give the chance to that firm to take voluntarily corrective and preventive actions and to immediately comply with the Federal Food, Drug, and Cosmetic Act.

However FDA can take the enforcement action even without issuing the warning letter as there is no prerequisite to issue Warning Letter before taking enforcement action.

FDA can also take the enforcement action without issuing the warning letter for examples:

If FDA finds that:

The history of repeated similar or significantly similar nature of violation even after notification to the firm.

The violation is obvious or intentional.

The product is adulterated.

The product found less potent or more potent or shows short contents than label claim.

There is a violation of current Good Manufacturing Practices (CGMP).

The product contains illegal pesticide residues.

FDA can also issue the Warning Letters to Government Agencies however; the method used to ensure compliance may vary.

If firm has taken adequate corrective action promptly and, if the agency concludes that a firm’s corrective actions are adequate; a Warning Letter may not be issued by FDA.

 

How to handle 483 observations and Warning Letter?

  • Gain understanding of observations noted by inspector and asks questions if you are not clear.
  • Take corrective action and preventive action immediately for the observation noted and discuss and demonstrate awareness of applicable regulations.
  • Provide the letter to FDA and give the commitment in writing, regarding the corrective actions.
  • Reply, in writing, within a time line as prescribed (usually 15 days) or request an extension and provide justification for request

If a decision is made by FDA, not to issue a Warning Letter to the firm because adequate corrective action has been taken, or the firm promised that corrective action is being taken.

Based on the firm’s letter which committing corrective action, agency may rely on the firm’s corrections or commitment regarding corrective actions.

However in future, if FDA observes that previous or similar violations have not been corrected by the firm, FDA may take the regulatory action even without further notice which may include seizure, injunction and civil penalties.

 

Conclusion:

483 are the observations given by the FDA Inspector as a result of inspection while warning letters issued when FDA finds significant violation of the regulations and if these significant violations not corrected promptly and satisfactorily, FDA initiates an enforcement action to that firm including Consent Decree.

 

For more information of warning letter   Refer US FDA website http://www.fda.gov

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