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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.
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.
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 ...
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 ...
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.
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 ...
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