Inspectors from the U.S. Food and Drug Administration (FDA) have a tough and thankless job. They are the unsung heroes that make sure the food we eat and the drugs we take are safe. Tens of millions of Americans take prescription or over the counter healthcare products daily. When we open our medicine cabinets in the morning, most of us take for granted that the drugs we take are safe, effective and not counterfeit.
Making sure our drugs are safe falls on the FDA. With 80% to 85% of prescription drugs now being manufactured overseas, that job is especially tough. The FDA is understaffed and spread too thin.
In the United States, the FDA can make unannounced inspections if they believe public safety is at risk. That makes sense, we wouldn’t want the military telling ISIS where the next cruise missile strike will land and we don’t tell drug companies suspected of lax sanitary practices that their facilities are about to be inspected.
In some countries, notably China and India, conducting surprise inspections is difficult. According to the FDA, folks at Indian drugmaker Vikshara Trading & Investments Ltd. took the inspection process to a new level.
Phony Strike to Prevent Inspection
New documents just released by the FDA suggest that Vikshara faked a workers’ strike and blocked an entrance to a plant about to be inspected. Worse, as is customary at Indian pharmaceutical manufacturing facilities, the FDA gave Vikshara advance notice of the inspection!
Even with weeks of advance notice, evidently Vikshara still couldn’t clean it’s facility and pass inspection.
According to the FDA warning letter sent to Vikshara Trading April 28th,
“On April 25, 2016, FDA contacted your firm to facilitate the inspection process and ensure appropriate records and personnel would be available. On June 18, 2016, you notified FDA that ‘factory workers and staff have gone on strike.’ On June 20, 2016, you informed FDA that workers had blocked off the entrance of the facility as part of their protest. As a result of these communications FDA cancelled our preannounced June 27, 2016, inspection.
“On July 15, 2016, you informed FDA that your employees remained on strike. On August 8, 2016, you provided purported evidence of the strike, including copies of employee resignation letters and a photograph of striking employees blocking the entrance to your facility.
“Despite your assertions that your employees were on strike, FDA obtained evidence that your firm actively manufactured numerous products…
“Your false statements to FDA regarding the purported strike at your facility delayed FDA’s scheduling and conducting of a preannounced inspection.”
According to the FDA, Vikshara knew as early as April of 2016 that its facility would be inspected in late June. It wasn’t until October 18th that FDA was finally able to gain entry to the facility, however. Even, the inspection could not be completed.
The FDA says that inspectors were denied entry into a vessel room and a packaging area. We can only imagine the conditions of those rooms!
Vikshara Trading Fails to Produce Records
The company also failed to provide records when asked. The FDA requires companies that sell or distribute pharmaceutical products in the U.S. to maintain extensive quality assurance records as well as training records, equipment maintenance, environmental testing and the like. The FDA does this to insure there are adequate safeguards to prevent adulterated or contaminated drugs from harming patients.
A more frequent concern is to insure products are neither under potent or too potent.
According to the FDA, Vikshara Trading promised the records to inspectors back in October. As of April 28th, the records still have not been received. Over a year after the FDA gave the company notice of an inspection and records still have not been produced.
When the limited inspection finally did occur, what rooms the company did allow the FDA to inspect were often dark! The inspectors had to use flashlights. The company wouldn’t turn on the lights.
What they could see was quite disturbing. Powder caked on floors, finished product covered in dust and trash scattered everywhere. Current cGMP (current good manufacturing practices regulations) require prescription pharmaceutical products to me manufactured in sterile facilities. State of the art pharmaceutical plants spend millions of dollars building clean rooms with specialized air filtration systems. (We are investigating one offshore facility where the air conditioners are filled with mold and the water used in the manufacturing process comes from a dirty river – it is brown in color!)
The FDA issued an import alert in February for products made by Vikshara Trading. We are not aware of any prescription pharmaceuticals made by the company. To our knowledge, the company sells over the counter products for distribution in the U.S. Still, those products are required to be safe.
cGMP Violations and Whistleblower Awards
The behavior by Vikshara Trading was certainly over-the-top but it is not an isolated incident. We are aware of many cGMP violations at both US and offshore pharmaceutical plants. When the product involves life-saving drugs, these violations could be fatal.
Although the FDA is understaffed, a U.S. Civil War era statute helps level the playing field. The federal False Claims Act pays huge awards to insiders with knowledge of cGMP violations. Improper manufacture, unsterile conditions, product that is under strength… any of these violations can lead to a whistleblower award.
To be eligible for an award, the improper conduct must involve drugs for which either Medicare or Medicare offers reimbursement. (That is virtually every prescription drug sold in America.)
If you have inside information about serious quality control issues at a pharmaceutical manufacturing facility, call us. You may be eligible for an award and you may save a life.
Not a resident or citizen of the U.S.? Don’t worry. There is no residency requirement to receive an award.
To see if you qualify for an award, call us. Our whistleblower clients have received tens of millions of dollars (USD) of award monies in recent years. You could be next.
The consultation is free, confidential and without obligation. If you hire us, we only get paid if you receive and collect an award. For more information, visit or pharmaceutical fraud whistleblower page or contact attorney Brian Mahany at or by phone at (414) 704-6731 (direct).
Mahany Law – America’s Pharmaceutical Fraud Whistleblower Lawyers
Short infographic video on cGMP by Pharma Buddy.