If you are a manufacturer or a processor of FDA-regulated products, sooner or later, you can expect a visit from FDA. The purpose of this visit is to verify compliance with all relevant regulations — most commonly referred to as an “FDA inspection.” But not all inspections are created equal.
FDA Inspections
The four different types of inspections conducted by FDA are:
Pre-Approval Inspections are conducted when an organization makes a submission to the FDA requesting to market a new product. The purpose of a pre-approval inspection is to verify the data included on the application and to confirm the facility is suitable for manufacturing the product.
Routine Inspections are mandated by law for every two years and use a risk-based approach to determine inspection frequency. They follow a prescribed method known as Quality System Inspection Technique (QSIT),Organizations should conduct operations as though an inspection might be initiated on any given day, thus always are prepared and ready for an inspection.
Follow-up Inspections are used if the organization was issued significant 483 observations or other enforcement actions including warning letters or injunctions during a previous inspection. The FDA will inspect and verify the actions taken in response to those observations. The FDA is confirming the organization has responded adequately and corrected any previous violations.
For-cause Inspections occur when consumers or employees report an issue to the FDA. Additionally, for-cause inspections can be triggered by reportable events that may have caused significant harm, death, or a product recall.
FDA Forms
There are three basic forms used by the FDA during an inspection are:
Form 482 (notice of inspection)
When the FDA begins an inspection, a Form 482 (notice of inspection) will be presented, along with contact information. The 482 explains the agency’s inspectional authority and provides expectations for the inspector and the firm. The 482 is issued to the organization’s top management official or the most responsible person at the site at the time of the inspection.
Form 483 (inspectional observations)
Contains the list of observations made by the FDA representative(s) during the inspection. These observations do not represent a final agency determination regarding compliance. The 483 formally notifies the organization’s top management of objectionable conditions or practices relating to violations of the (FD&C) Act that were observed during the inspection.
Form 484 (receipt for sample)
is issued at the end of an inspection describing any samples obtained during the inspection. The 484 is given to the same individual who received the FDA 482.
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Resource Person: Dr.Prasadhi Shiva
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