What does an FDA inspection involve?
An FDA inspection will be conducted as necessary in the judgment of FDA to determine compliance with the applicable provisions in 21 CFR Part 1271 (21 CFR 1271.400(a)). 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 21 CFR Part 1271. FDA will call upon the most responsible person available at the time of the inspection of the establishment and may question the personnel as necessary to determine compliance with the provisions of 21 CFR Part 1271 (21 CFR 1271.400(c)). FDA representatives may take samples, may review and copy any records required to be kept under 21 CFR Part 1271, and may use other appropriate means to record evidence of observations during inspections (21 CFR 1271.400(d)). Financial records and personnel records are not required records under 21 CFR
