Response to FDA 483 warning letter

Response to FDA 483 Observations.

FDA 483 is issued to company management after completing FDA inspection, if FDA inspector observed any non-conformities (objectionable conditions or violations). You will get 15 days time to prepare and submit the response letter. Please make sure you understand the observations before the FDA inspector leave the company, if you have any questions or need clarification, you can discuss with the FDA inspector at the time of closing meeting.

It is important how you respond to FDA 483 letter, the FDA 483 response letter must have a root cause analysis, corrective and preventive action plan, and a time-frame to correct the observations .

Steps in FDA 483 warning letter response

Understand the non-conformity (objectionable conditions or violations)
Initiate a CAPA (Corrective and Preventive Action)

Describe the non-conformity
Identify the result of non-conformity
Identify the root cause
Develop a corrective and preventive action plan
Set time frame for CA/PA plans
Develop a plan for CA/PA verification

Prepare a 483-response letter with response to each observation and attach corresponding CAPA document
Submit the letter to the FDA District office mentioned in the FDA 483 letter

How LMG can help with FDA inspection?

Liberty Management Group LTD, is a Leading medical device GMP consultant based at greater Chicago area with experience in FDA 21 CFR 820 regulations, CE Marking and ISO 13485.

We can help you to:

Prepare quality manual
Prepare Quality system procedures
Conduct internal audit
Conduct training
Conduct MRM Meating
CAPA documentation
GAP Analysis
FDA Audit support
Maintain your quality system up-to-date

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