GMP: New FDA Inspection Guidance gives the Agency more Power
The U.S. Food and Drug Administration (FDA) is obliged to carry out inspections of facilities at reasonable times, within reasonable limits and in a reasonable manner. However, sometimes the FDA is not able to perform their tasks. Some companies delay or deny an inspection or even refuse the inspector to enter. FDA has published the final Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.