21 CFR 1270.41 - Inspections.
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(a) An establishment covered by these regulations in this part, including any location performing contract services, shall permit an authorized inspector of the Food and Drug Administration (FDA) to make at any reasonable time and in a reasonable manner such inspection of the establishment, its facilities, equipment, processes, products, and records as may be necessary to determine compliance with the provisions of this part. Such inspections may be made with or without notice and will ordinarily be made during regular business hours.
(c) The inspector shall call upon a responsible person of the establishment and may question the personnel of the establishment as the inspector deems necessary.
(d) The inspector may review and copy any records required to be kept pursuant to part 1270.
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.