Question 1

What is FDA INSPECTED certification?

Accepted Answer

FDA INSPECTED certification is a quality standard that verifies a laboratory or organization meets specific regulatory and operational requirements. For CROs, holding FDA INSPECTED certification demonstrates that their facilities, procedures, and staff comply with industry-recognized benchmarks for data integrity, safety, and scientific rigor required by regulatory agencies.

Question 2

Why is FDA INSPECTED certification important for CROs?

Accepted Answer

FDA INSPECTED certification is important because regulatory agencies often require data from FDA INSPECTED-compliant facilities for drug approval submissions. Working with a FDA INSPECTED-certified CRO reduces the risk of regulatory rejection, ensures study data meets quality standards, and gives sponsors confidence that the CRO's processes have been independently verified against established benchmarks.

Question 3

How do I verify a CRO's FDA INSPECTED certification status?

Accepted Answer

Request a copy of the CRO's current FDA INSPECTED certificate and check its validity dates. Cross-reference with the issuing body's public registry when available. During your qualification audit, review inspection reports, corrective action history, and any conditions placed on the certification. Ask for documentation of ongoing compliance activities such as internal audits and proficiency testing.

FDA INSPECTED Certified CROs

Aenova Group Munich

Corden Pharma Switzerland

Korea United Pharm

Neopharm Israel

Recipharm Uppsala

Sai Life Sciences