Q: When we prepare a 483 response letter to an FDA notice of inspectional observations, do you recommend we include supporting documents such as SOPs and training records — even those we’ve already shared with the on-site FDA inspector?
A: Yes, and here’s the primary reason: When FDA inspectors are on-site, they collect far more documentation than they have time to fully review and organize. There may be as many as 30 or more documents attached to an inspector’s Establishment Inspection Report (EIR), making it difficult for another person within FDA to identify specific documents and cross-reference them with your response letter.
Your 483 response will be reviewed by FDA officials other than the original inspectors, so you have an opportunity to communicate with a different audience and provide solid evidence of your compliance. Include a reference index so they can see examples of supporting documents and signed and implemented procedures.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]It’s better to re-submit important documents, putting them in front of decision-makers who otherwise might easily miss them.[/pullquote]
We see a significant increase in FDA Warning Letters stating “you said you did X, Y and Z, but you did not provide any evidence that you had actually done them”. Given that trend, we believe it’s better to re-submit important documents, putting them in front of decision-makers who otherwise might easily miss them.
For more information on preparing for and responding to FDA inspections, attend EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 Compliance training class.