Glossary
FDA inspection terms, in plain words.
What a Form 483 is, how an EIR differs, what NAI, VAI and OAI mean, and the other terms you meet before, during and after an FDA inspection.
Inspection documents
Form FDA 483 (inspectional observations)A Form FDA 483 is the list of inspectional observations an FDA investigator gives a firm's management at the end of an inspection, when they saw conditions that in their judgment may violate the Food, Drug, and Cosmetic Act.Establishment Inspection Report (EIR)An Establishment Inspection Report is the FDA investigator's narrative report of an inspection. It's longer and more detailed than the Form 483.Response to a Form 483A 483 response is the firm's written reply to the observations on a Form 483, usually describing corrective actions and timelines.FDA warning letterA warning letter is FDA's notice to a company or person that FDA believes it has found significant violations of federal requirements. It asks for a response within a set time.Warning letter close-out letterA close-out letter tells a firm that FDA has evaluated its corrective actions and is satisfied that the violations in a warning letter were addressed. It applies to warning letters issued on or after September 1, 2009.FDA import alertAn import alert lets FDA detain future shipments of a product with a history of violations without physically examining them ("detention without physical examination", DWPE).
Inspection outcomes
How FDA classifies inspectionsAfter an inspection, FDA assigns a final classification (NAI, VAI or OAI) based on the inspection findings and the firm's response.No Action Indicated (NAI)NAI is FDA's inspection classification meaning no objectionable conditions or practices were found. The facility is in an acceptable state of compliance and usually wasn't issued a Form 483.Voluntary Action Indicated (VAI)VAI means objectionable conditions or practices were found, but FDA isn't prepared to take or recommend administrative or regulatory action. The facility usually received a Form 483.Official Action Indicated (OAI)OAI means regulatory and/or administrative actions are recommended. The facility is in an unacceptable state of compliance.
Sites and standards
FDA Establishment Identifier (FEI)The FEI (FDA Establishment Identifier) is a unique number FDA assigns to identify firms associated with FDA-regulated products. Each location has its own FEI, so one company can have many.Pre-approval inspection (PAI)A pre-approval inspection is an FDA inspection of a manufacturing facility in support of a pending drug application, run under compliance program 7346.832.Current Good Manufacturing Practice (CGMP)CGMP is the set of FDA requirements for the methods, facilities and controls used to make drugs. A drug is deemed adulterated if its manufacture doesn't conform to CGMP.