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# FDA Probes Data Integrity Concerns at India CRO
- URL: https://www.fdaweb.com/fda-probes-data-integrity-concerns-at-india-cro/
- Published: 2025-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:56:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158915

FDA is notifying NDA and ANDA holders about data integrity and study conduct concerns with bioequivalence studies conducted at contract research organization (CRO) Raptim, which is based in Navi Mumbai, India. An [agency notice](https://www.fda.gov/drugs/drug-safety-and-availability/fda-pharmaceutical-companies-certain-studies-conducted-raptim-research-pvt-ltd-are-unacceptable?ref=fdaweb.com) says that *in vitro* studies conducted by Raptim are not acceptable, and if any studies were relied on for any product approval then they must be repeated at study sites that do not have data integrity concerns. 

“Applications with *in vivo* studies conducted by Raptim will be handled on a case-by-case basis during the course of a standard submission review,” FDA says. “Study concerns can be addressed by the applicants with appropriate steps, which may include providing additional information to justify how the data from the studies can still be relied upon, re-analyzing the study samples and re-conducting statistical analysis to demonstrate bioequivalence, or conducting a new study. Sponsors may contact the relevant FDA review division in the Office of Generic Drugs or the Office of New Drugs for further information or clarification.”