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# Panexcell, Synchron Studies Are ‘Unacceptable’: FDA
- URL: https://www.fdaweb.com/panexcell-synchron-studies-are-unacceptable-fda/
- Published: 2021-09-21T12:00:00.000Z
- Updated: 2026-09-14T17:15:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150189

FDA is telling NDA and ANDA sponsors that clinical and bioanalytical studies conducted by Synchron Research Services, located in Ahmedabad, Gujarat, India, and Panexcell Clinical Lab, Navi Mumbai, India, are not acceptable because of data integrity concerns. An agency [notice](https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-panexcell?ref=fdaweb.com) says the studies must be repeated.

The notice says the agency action is based on an inspection at the two facilities and analysis of study data generated at the companies and submitted in several applications that found significant instances of misconduct and violations of federal regulations, resulting in the submission of invalid study data to FDA.

The agency sent each facility a Notice of Violation (links included in the notice) detailing its findings.