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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.
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 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 certificate of occupancy is evidence that the building complies substantially with the plans and specifications that have been submitted to, and approved by, the local authority. It complements a building permit —a document that must be filed by the applicant with the local authority before construction to indicate that the proposed ...
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.