Why Choose Reliant FDA Experts?

Warning Letter & 483 Responses

After an FDA inspection, if the investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts, an FDA Form 483 is issued to firm management at the conclusion of the inspection. Written responses to FDA Form 483s are not a regulatory requirement. However, companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan. A well written response letter and timely implementation of the corrective action plan often help a company avoid further actions (i.e., Warning Letter) by the FDA.

COMMON ISSUES, MISTAKES AND PITFALLS

  • Not including both corrective and preventive actions in responses
  • Providing access and copies to the FDA without keeping an internal list and/or copies
  • Responses that do not include a date that CAPAs and commitments will be completed
  • Use of re-training as a response without additional actions
  • Missing response commitment deadlines

EXAMPLES OF THE HELP RELIANT CAN PROVIDE

  • Generate a Warning Letter Response
  • Generate a Form 483 Response
  • Generate a Quality Program Improvement Plan to Address FDA Commitments
  • Manage Implementation of FDA Commitments

ASSOCIATED JOURNAL ARTICLES AND COMPLIANCE TIPS
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