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Form FDA 483. The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". [1] Form FDA 483, [2] "Inspectional Observations", is a form used by the FDA to document and communicate concerns discovered during these inspections.
Request for waiver. In a manufacturing environment, a request for waiver (RFW) is a request for authorization to accept an item which, during manufacture or after inspection, is found to depart from specified requirements, but nevertheless is considered suitable for use as is or after repair by an approved method.
An inspection is, most generally, an organized examination or formal evaluation exercise. In engineering activities inspection involves the measurements, tests, and gauges applied to certain characteristics in regard to an object or activity. The results are usually compared to specified requirements and standards for determining whether the ...
A Warning Letter is one of the Agency's principal means of achieving prompt voluntary compliance with the Act. [1] While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel. [2] The FDA considers a warning letter informal and advisory.
First article inspection. A First Article Inspection ( FAI) is a production validation process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report.
Request for information. A request for information ( RFI) is a common business process whose purpose is to collect written information about the capabilities of various suppliers. [1] Normally it follows a format that can be used for comparative purposes. An RFI is primarily used to gather information to help make a decision on what steps to ...
In many jurisdictions, parties who wish to inspect documents must deliver a formal request for inspection to the parties that possess those documents. [6] These requests usually must describe the documents that would be inspected. [7] Once the request has been delivered to the party in possession of the documents, that party generally must ...
Inspection in manufacturing is conducting inspection during the production process. This approach of inspection helps to control the quality of products by helping to fix the sources of defects immediately after they are detected, and it is useful for any factory that wants to improve productivity , reduce defect rates, and reduce re-work and ...