For postmarket inspections, each year FDA prioritizes its surveillance inspections using a risk-based model which considers multiple risk factors (although being selected for an inspection does not necessarily signal a quality issue). Additionally, FDA can inspect facilities on a for-cause basis if information warrants it.

Most manufacturers comply with CGMP requirements. Historically, more than 90% of inspections found facilities to have acceptable CGMP compliance.

When FDA investigators observe issues during an inspection, they use Form FDA 483 to document their observations related to CGMP compliance at the conclusion of the inspection. A Form FDA 483 does not constitute a final agency determination of whether any condition violates CGMP. A company generally has 15 business days to provide FDA with a voluntary response to the Form FDA 483.

FDA reviews the following information once an inspection is completed:

• Form FDA 483, if issued 
• the establishment inspection report developed by the investigator(s)
• evidence collected during the inspection or via other agency activity
• the company’s response to the Form FDA 483 (if provided to FDA), including plans for corrective actions
• other information as appropriate

During the compliance review, the agency also considers:

• requirements outlined in FDA regulations 
• technical standards 
• scientific consultations from across the agency and literature
• manufacturing operations of the facility and the drug(s) they produce
• the potential for patient or consumer harm based on risk of the quality deviations

FDA classifies inspections based on observations made during a CGMP inspection:

• No action indicated (NAI) classification indicates there were no objectionable observations found during the CGMP inspection.
• Voluntary action indicated (VAI) classification indicates that the investigator relayed objectionable observations at the end of the CGMP inspection. Based on the nature of observations and the firm’s commitments to voluntarily correct deficiencies, an official action indicated classification is not warranted. Usually, the facility was issued a Form FDA 483 at the conclusion of the CGMP inspection.
• Official action indicated (OAI) classification indicates a facility is in an unacceptable state of compliance. Generally, the facility was issued a Form FDA 483 at the conclusion of the CGMP inspection.

FDA strives to complete its CGMP classification of human drug facility inspections within 90 days of the end of the inspection. The agency sends the facility a letter with the classification (examples: NAI, VAI and OAI letters) and generally posts the classification to the data dashboard.

The facility-specific data dashboard contains information on surveillance and for-cause inspections for drugs, biologics and other medical products dating back to 2009, as well as data on a facility’s inspection history, including warning letters.

Additionally, for facilities with an OAI-classified CGMP inspections, FDA may withhold:

• approval of any pending drug applications that list the facility
• export certificates for drugs intended for distribution outside of the U.S.
• CGMP declarations for drugs intended for distribution outside of the U.S.

Government purchasing contracts may also be adversely impacted by an OAI classified inspection.

Generally, FDA will only change an OAI inspection classification after a company implements comprehensive corrective and preventive actions that are verified through an onsite follow-up FDA inspection.

FDA uses a robust set of tools to promote prompt voluntary compliance with CGMP requirements and to protect patients and consumers from poor quality drugs. This gives the facility an opportunity to take voluntary corrective actions and work towards sustainable compliance. Examples include:

• issuing a warning letter to a facility to notify a firm of federal law violations, and recommend a facility allocate appropriate resources to fully correct the violations and prevent their recurrence
• issuing an untitled letter for CGMP-related issues, which are not necessarily posted to FDA.gov
• having a regulatory meeting between company leadership and FDA when the agency wants to conduct a detailed technical discussion with the company
• recommending or requesting a drug recall
• placing a company on import alert to help stop their drugs from entering the U.S. market. FDA uses import alert 66-40 and others for CGMP-related concerns

FDA takes a risk-based approach to its regulatory activities taking into account medical need, risk of shortage and ability to assure drug quality.

If a facility fails to address CGMP violations, the agency may take additional action brought in federal court by the Department of Justice on behalf of FDA, such as:

• injunctions, including consent decrees, which can shut down a facility until it complies with CGMP requirements

• seizures of violative drugs in the domestic supply chain from a company or warehouse

• criminal prosecution

Additionally, when we become aware of drugs that may present a safety hazard or other health risk to consumers, we may issue public statements, such as a press release or an alert, to notify health care practitioners and the public regarding such drugs as part of our public health mission.

• View the webinar on understanding FDA inspections and data for more information.
• CDER Frequently Requested or Proactively Posted Compliance Records

Search for publicly available Form FDA 483 inspection findings, untitled letters and other correspondence to FDA-regulated companies located within or outside of the U.S.

• ORA Frequently Requested or Proactively Posted Compliance Records

Search publicly available Form FDA 483 inspection findings and other correspondence to FDA-regulated companies located within the U.S.