> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Semler Research Sues FDA Over Inspection
- URL: https://www.fdaweb.com/semler-research-sues-fda-over-inspection/
- Published: 2018-01-24T12:00:00.000Z
- Updated: 2026-09-14T23:16:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140588

Semler Research Center (SRC), a contract research organization based in Bangalore, India, is suing FDA and some of its inspection and other employees in a California federal court, claiming the agency and its staff violated the company’s Fifth Amendment rights and intentionally inflicted financial distress, interfered with the company’s economic advantage, and acted negligently, all under the Federal Tort Claims Act. The [suit](http://www.fdaweb.com/download.php?file=document%2813%29.pdf) says the Fifth Amendment violation is based on the “arbitrary treatment of SRC by FDA, HHS, federal employee defendants, and USA denying SRC life, liberty, or property outside the sanction of law…. SRC has been arbitrarily denied life, liberty, or property without meaningful opportunity to be heard, have matters pertaining to it heard and determined by an impartial trier of fact and trier of law, and the right to give testimony and present relevant evidence to (and have said testimony and evidence considered by) an impartial trier of fact and trier of law.”

The case involves a 9/29/15 FDA inspection at a company facility in Bangalore and its concern with a computer spreadsheet that the company believes was created by a “rogue employee” before that employee left for a position with a competing contract research organization.

SRC says the agency inspectors reviewed data for 30 studies and incorrectly determined that the company had been manipulating the data and that the study results could not be verified. The company says it advised FDA that it was submitting the studies for an independent audit and asked that the agency conduct its own independent audit of them. It claims that the audit sought by the company cleared it of any wrongdoing.

However, it says, on 4/9/16, without having conducted an independent audit or spoken to the people involved with the studies shown on the questioned spreadsheet, FDA issued an untitled letter alleging that the company failed to follow agency guidelines and law in providing its services to customers. And on 4/20/16, SRC says, FDA [posted](http://www.fdaweb.com/download.php?file=document%2813%29.pdf) a Web site notice saying that all SRC studies, whether previously approved and whether clinical or bioavailability/bioequivalence, were unacceptable.

“FDA took the actions despite having no evidence of data manipulation other than the ‘suspect spreadsheet’ and despite there never having been any negative reports related to any pharmaceutical FDA had previously approved and that was on the market,” SRC declares.

The company says that other regulatory agencies have doubted the credibility of all the research SRC has conducted, based on the FDA findings, which has hurt the company’s reputation and good will and has cost it millions of dollars in lost business and the possible sale of the company. It claims that the agency actions were taken without giving SRC due process and with the express intent to inflict financial harm on the company and interfere with its economic advantage.

SRC is asking for a jury trial and damages in excess of $50 million.