How To Be Ready For A FDA Inspection
As with most aspects of life, preparation and planning provide a stable foundation for determining the success of any operation. This is especially true in the pharmaceutical industry. One of the most stressing times for most people involved with this industry is an audit.
This series of articles will focus primarily on a FDA 483 inspection but will provide an outline of necessary preparations for internal audits, corporate audits, customer audits, and audits by other regulatory agencies. Each company should have a standard operating procedure in place for any inspection and should verify that all local or corporate standards concerning the audit are met.
The FDA inspects all companies that manufacture, process, pack or hold FDA-regulated products including contract manufacturing facilities, contract testing laboratories, and clinical study sponsors.
Auditing alone cannot be relied upon to ensure quality! Your actions before, during, and after the audit will ultimately determine your level of compliance.
Video on How To Handle A FDA Inspection
FDA Inspection & Audit Resources
Free FDA 483 Action Package
Compliance Insight has created a free FDA 483 Action Package to help you respond to a FDA 483. Click the button below to learn more and download you copy today.