Notifications on Data Integrity

FDA is committed to protecting the health of the American public by holding approved products to high standards of quality, safety, and efficacy. 

FDA has issued the following notifications on data integrity:

• Notification to Pharmaceutical Companies: Certain studies conducted by Raptim Research Pvt. Ltd. are unacceptable (March 28, 2025)
• Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Synapse Labs Pvt. Ltd. are Unacceptable (June 18, 2024)
• Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Panexcell Clinical Lab or Synchron Research Services Are Unacceptable (September 16, 2021)
  • Questions and Answers Regarding Data Integrity Violations at Panexcell Clinical Lab and Synchron Research Services (September 16, 2021)
• Notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Semler Research Are Unacceptable (April 20, 2016)