What Blood Establishments and Biologics Companies Can Expect After an FDA Inspection
From blood supply to vaccines — blood establishments and biologics companies handle complex products that are fundamentally important to human life. It is no wonder that the industry faces some of the toughest regulations and standards today.
The Center for Biologics Evaluation and Research (CBER) is the primary FDA entity that regulates biological products. CBER also regulates medical devices and tests that protect blood and cellular products from infectious agents, as well as machines and software used to collect blood and blood components.
However, when it comes to inspection of blood and biologics companies, the Office of Regulatory Affairs (ORA) takes the lead, while CBER has the option of participating. ORA is the entity responsible for all of the FDA’s field activities. Both CBER and the Center for Drug Evaluation and Research (CDER) may choose to participate in pre-approval inspections of firms with submissions for a new drug/biological product.
For those who just survived an FDA inspection, or those preparing for one, the question is: What happens after inspection?
Patricia Holobaugh, chief of the Bioresearch Monitoring Branch in CBER’s Division of Inspections and Surveillance, outlined the post-inspection process for blood and biologics companies in a presentation at a conference sponsored by the Society of Clinical Research Associates last year. According to Holobaugh, here are some of the things you can expect after an FDA inspection.
End of Inspection
Classification of Inspection
Possible Actions for OAI
Actions for Inspected Party
Actions on Applications
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