FDA 483 Inspection, Observations & Warning Letter

The FDA form 483 is officially called a Notice of Inspectional Observations, commonly referred to simply as an FDA 483. An FDA 483 is issued to an organization by the FDA investigator(s) for violations against GMP regulation/quality system or conditions that violate the Food, Drug, or Cosmetic Act. This is applicable for food, drug, device or cosmetic.

Organizations are encouraged to respond to the FDA 483 warning Letter(s) for each inspectional observations by writing CAPA signed by the respective initiator and department head with action plan expeditiously in a specified timeframe. The quality and promptness of your response to this letter are extremely important.

I 3 CONSULTING can support organizations in preparing an effective response to an FDA 483 warning letter by understanding the actual situation for the cause of observation, analyzing the root cause, discuss with process owner for the immediate corrective action.

As part of our services, we will:

  • Analyze the observation given to manufacturer in US FDA 483 form.
  • Identify the root cause of the observation in consultation with client team and process owner.
  • Support process owner to initiate CAPA (against FDA 483 warning letter).
  • Submit an initial response to FDA 483 warning letter with a possible timeline to close each FDA 483 / observation within 10 to 14 days.
  • Assist organization to develop a roadmap, Identify responsible process owner, guide him/her on what to be done.
  • Guide, review, correct, modify evidence submitted by the client team against each respective CAPA.
  • Support in answering to US FDA during the submission of response and evidence.

It is very important to know the below information for all of those who received FDA 483's. FDA soon handover the 483's put pressure on manufacturers to respond within 15 workdays after the close of an inspection.

Refer below link to know more about how to submit an initial response to FDA 483 click here

Manufactures (FDA 483 warning letter holders) must know a poor non-technical response will lead to permanent warning and chances of further enforcement action which leads to additional inspection. It's important to include only practical corrective actions and timeframes in an FDA 483 response. A CAPA without much thought and improper corrective action and a practical closing date. The role of our services is important at this stage.

Check our pricing / Fees from this link click here

To know more about FDA 483 / US FDA Inspection, Observations, Warning Letters and how to prepare and send FDA response, customers can write to enquiry@i3cglobal.com for a quick reply.

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