Who does the FDA audit?

Who does the FDA audit?

the FDA inspector
The FDA Investigation Process FDA Form 482 essentially provides notice of an FDA audit to the manufacturing facility. The form is completed by the FDA inspector who will be conducting the audit. The form will cite statutory authority that gives the FDA the ability to audit the facility.

Who conducts FDA inspections?

Consumer Safety Officers
Who conducts FDA inspections? A. Almost all FDA inspections are conducted by Consumer Safety Officers in the Office of Regulatory Affairs (ORA). 1 Consumer Safety Officers, colloquially called investigators, are trained to conduct inspections for a specific FDA-regulated commodity.

What is a 482 FDA?

When the FDA begins an inspection, a Form 482 (notice of inspection) will be presented, along with contact information in the event a 483 response is issued. The 482 explains the agency’s inspectional authority and provides expectations for the inspector and the firm.

What is VAI in FDA?

VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action. OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended.

What FDA audits?

The Food and Drug Administration (FDA) conducts inspections and assessments of regulated facilities to determine a firm’s compliance with applicable laws and regulations, such as the Food, Drug, and Cosmetic Act and related Acts.

Can FDA audit outside US?

An official with the US Food and Drug Administration (FDA) said the agency has no plans to resume onsite foreign inspections for operations that are not deemed “mission critical” during the COVID-19 public health emergency.

What is an FDA investigator?

An individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is dispensed to a subject.) In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. [21 CFR 312.3]