TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER L - REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION

PART 1270 - HUMAN TISSUE INTENDED FOR TRANSPLANTATION

subpart d - INSPECTION OF TISSUE ESTABLISHMENTS

1270.41 - Inspections.

  (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.

  (b) The frequency of inspection will be at the agency's discretion.

  (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.

  (e) The public disclosure of records containing the name or other positive identification of donors or recipients of human tissue will be handled in accordance with FDA's procedures on disclosure of information as set forth in 21 CFR part 20 of this chapter.