In an In-Pharma article by Dan Stanton, Robert Fish discusses how to avoid 483 observations during audits. Fish, who served as FDA inspector for over 30 years, stressed the importance of knowing application details and training employees through mock inspections.
In order to make a positive first impression, the site must be orderly and all interactions must be courteous and respectful. FDA has the right to question whomever they choose, so it is in a company’s best interest to encourage employees to be honest, but not over-informative.
To read Stanton’s article, click here. Need help with 483 or warning letter remediation? The team at Pearl Pathways can help. Contact us.