Common Terms Used in USFDA Inspections

Types of USFDA Inspections

  1. Pre-approval/Application-based inspection: conducted before the USFDA approves a new drug, biologic, or medical device for marketing in the US.
  2. Routine/GMP/Surveillance/Post marketing inspection: conducted periodically to ensure that the manufacturing facilities and processes continue to comply with cGMP regulations.
  3. Compliance follow-up: conducted to verify that a facility has taken corrective actions to address any deficiencies found during a previous inspection.
  4. For Cause inspection: conducted in response to a specific incident or a complaint that raises concerns about the safety, efficacy, or quality of a product.

The agency also conducts inspections to verify the reliability, integrity and compliance of r&d facilities, testing labs, cmo, clinical and non-clinical research being reviewed in support of pending applications.

FDA Forms 482, 483 and 484

  1. Form 482: Notice of Inspection, is a heads-up from the FDA to the company before they come for an inspection.
  2. Form 483: Inspectional Observations form, lists any observations and deficiencies found during the inspection and explains why they are important to address. It serves as a warning to the company to take corrective actions to address the issues and ensure compliance with regulations.
  3. Form 484: Receipt of Samples form, is used by the FDA to document the samples taken during the inspection. This form is crucial in keeping track of the samples and ensuring they are properly handled and analyzed.

Establishment Inspection Report (EIR)

A comprehensive report that provides a detailed account of the inspection, from start to finish. It includes a summary of the inspection, photographs, and narrations of any issues found. This report serves as a record of the inspection and is used by the FDA to determine the compliance status of the facility.

Outcome of the Inspection

  1. OAI (Official Action Indicated): Significant issues that require corrective actions and may result in regulatory enforcement actions
  2. VAI (Voluntary Action Indicated): Concerns that fall below the threshold for regulatory action but require attention for potential improvements
  3. NAI (No Action Indicated): No significant issues were found during the inspection or that the issues do not warrant any regulatory action.

Warning Letters are issued when significant violations are found during an inspection and the company fails to take corrective actions. These letters serve as a warning and may result in further regulatory enforcement actions if the issues are not addressed.

Import Alert, indicates that the company’s products do not meet the required standards and are not allowed to be imported into the United States. This is a serious escalation from Warning Letters and may result in severe consequences for the company.

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Resource Person: Bharathi Kodali

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