75 Executive Drive, Suite 114, Aurora, Illinois, USA - 60504

Phone : (630) 270-2921
E-mail : info@fdahelp.us

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

Contact Us

75 Executive Drive, Suite 114
Aurora, Illinois, USA - 60504
Phone : (630) 270-2921
Fax : (815) 986-2632
E-mail : info@fdahelp.us