What does an FDA inspection of an HCT/P establishment involve?
An FDA inspection will be conducted to determine compliance with the applicable provisions in 21 CFR Part 1271. The FDA inspection may include, but is not limited to, an assessment of the establishment’s facilities, equipment, finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers, and controls required to be maintained under the regulations. FDA representatives may review and copy any records required to be kept under 21 CFR part 1271. Financial records and personnel records are not required records under part 1271. For reproductive establishments, inspection will be limited to determining compliance with the applicable provisions contained in subparts A, B, C, and sections 1271.150(c) and 1271.155 in subpart D. Are FDA HCT/P establishment inspections conducted during regular business hours? An FDA inspection will ordinarily be performed during regular business hours and may be made with or without prior notification. The frequen
