USFDA’s Inspections Program for Human Drugs

The Office of Regulatory Affairs (ORA) is the lead office for all field activities at the FDA. They are responsible for conducting the inspections.

FDA prioritizes inspections by risk and gives higher risk situations a higher priority.

Generally FDA conducts 4 types Audits

Pre-Approval Facility Evaluations And Inspections: Pre-Approval Facility Evaluations and Inspections directly support the assessment of marketing applications by assuring that any manufacturing facility named in the application is capable of manufacturing the drug in conformance to Current Good Manufacturing Practice (CGMP) requirements and that the data submitted in the application are accurate and complete.
Post-Approval Facility Inspections: Post-Approval Facility Inspections are similar to Pre-Approval Facility Inspections in that they are product specific, but are conducted after applications have been approved. This type of inspection focuses largely on the process validation lifecycle and any manufacturing changes that may have occurred following approval. Changes in perceived risk may also initiate such an inspection, even in cases where a Pre-Approval Inspection was not deemed necessary.
Surveillance Facility Inspections: This type of inspection is meant to monitor the conformance to CGMP requirements and is not necessarily an assessment of a specific product. Rather, it is a system-based inspection. The purpose of this type of inspection is to identify quality problems and adverse trends at facilities so that the FDA can develop strategies to mitigate them.
For-Cause Facility Inspections: This type of inspection is meant to gather additional information to determine the quality of marketed product and to determine whether enforcement actions are warranted.
Criteria for USFDA’s Pre Approval Inspections
First time facility is named in an application
First application by the applicant
First ANDA for an approved drug
New molecular entity
Narrow therapeutic range drugs
New manufacturing process or dosage form for facility
High – risk API
Numerous applications or site, process or product changes
OAI status or no recent inspections
More General Criteria
Difficult to manufacture drug
Site compliance Record
Corporate compliance Record
Recent inspections
Supply chain risks
Criteria for FDA Surveillance Inspections
Compliance history of the establishment
Record, history and nature of recalls linked to the establishment.
Inherent risks of drugs manufactured, prepared, propagated, compounded or processed at the establishment.
Inspection frequency and history of the establishment.
Inspections by foreign regulators
Patient exposure
Hazard signals (e.g., FARs, adverse events)
Inherent product risks