FDA Inspection

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The FDA Inspection and Enforcement Process: A Guide for HCT/P Manufacturers and Providers

by admin on January 26, 2018 No comments

stem cell therapyBy: Matthew Fischer

In November 2017, the U.S. Food and Drug Administration (FDA) issued new guidance regarding its current interpretation of the minimal manipulation and homologous use criteria set forth in 21 CFR Part 1271(a) and the agency’s view on the same surgical procedure exception under 21 CFR 1271.15(b).  Additionally, the FDA issued a notice to all interested stakeholders that the agency intends to initiate increased discretionary enforcement over the next 36 months for HCT/P businesses.  Based on the agency’s latest position, it is important for HCT/P manufacturers and providers to understand the inspection process and be prepared to respond accordingly in this heightened regulatory environment.

The FDA is tasked with regulating HCT/Ps under the authority of Section 361 of the Public Health Service Act (PHS).  Within the FDA, the Center for Biologics Evaluation and Research (CBER) is responsible for ensuring the safety of these products and promoting corrective action.  In order to reach this goal, CBER is armed with an array of administrative actions to address violations of regulatory significance.  

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