The United States Food and Drug Administration (FDA) issued a stern warning questioning product safety at a major Indian pharmaceutical manufacturer. The company, Strides Pharma Science, makes several drugs and pharmaceuticals distributed in the U.S. The warning letter follows warnings from earlier this year.
July 2019 FDA Warning Letter to Strides Pharma Science Limited
On July 1st, the FDA issued an official warning letter to Strides Pharma. The agency’s letter was a follow up to an earlier inspection of the company’s manufacturing plant in Puducherry, India.
According to the FDA, Strides’ “methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP.” The agency concluded that’s its products were likely adulterated.
Much of the warning letter stems from shredded documents found by FDA inspectors during a tour of the facility. Officials found quality inspection records of drugs bound for the United States hidden in a drum located in a scrap yard.
Under federal law, drug companies are obligated to keep quality control records, even if the manufacturing plant is located outside the United States.
The FDA first alerted Strides about the issues after the inspection. The company acknowledged the problem but not to the FDA’s satisfaction,
“The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of your QU and the integrity and accuracy of your CGMP records.
“In your response you state the binder of CGMP documents in your scrap yard was ‘inadvertently come [sic] to scrap yard’ and that you were investigating the issue… In addition, you committed to strengthen your training program to include instructor-led classes geared towards good documentation practices.
“Your response is inadequate because, while you acknowledge the binder of CGMP records in your scrap yard, you did not assess other documents found in the scrapyard, nor did you assess how poor documentation practices affected distributed drug product or how you would strengthen your QU oversight. Your firm’s quality systems are inadequate.”
[cGMP refers to Current Good Manufacturing Practices, a set of rules published by the FDA to ensure the safety of pharmaceutical products. QU refers to Strides’ Quality Unit.]
The FDA was also concerned about how Strides treated questionable drug batches that were flagged by the company’s Quality Unit. According to the FDA, several times the company’s quality control inspectors identified drugs with impurities but never fully investigated what went wrong or how to prevent future problems.
The FDA says until the problems are corrected, it may withhold approval of any new drug applications made by Strides and refuse to allow the import of existing drugs made at that plant.
Strides Pharma Science has 10 new product applications pending with the FDA.
The company says, “Strides is committed to the highest standards of quality and compliance and will work collaboratively with the FDA to resolve all issues addressed in the warning letter.”
Of course, it said something similar after the inspection of their plant in late January 2019. Now that warning letter has been published, its ability to export drugs is in jeopardy and its stock price has dropped, we suspect the company might finally take some action.
In recent years, Indian drug makers have been hit especially hard by the FDA. The agency has issued warning letters to many Indian pharmaceutical manufacturers including Hetero Labs, Dr. Reddy’s Laboratories and Divi’s Laboratories. In the case of Hetero Labs, the FDA found the company “failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”
FDA Whistleblower Opportunities
Many of the drugs presently distributed in the United States are made overseas, much of the production coming from India and China. Even brand names drugs are often made by foreign “contract” manufacturers.
It is impossible for the FDA to be every place at once. In addition to thousands of drug companies worldwide, there are tens of thousands of companies that make the active pharmaceutical ingredients or “API” used in drugs. Some of these companies operate “open air” facilities in third world countries.
In theory, the FDA has the ability to make unannounced inspections at any facility if the companies are exporting their drugs to the United States. If you want to sell your drugs here, you must agree to inspections. As a practical matter, “surprise” inspections in foreign countries are rarely a surprise. That means it is shocking for FDA inspectors to find current quality control records in a dumpster during an inspection.
We worry that these occurrences happen daily. And that means the drugs in your medicine cabinet may be adulterated, contaminated, fake or understrength (sub potent). There is not much the average consumer can do but employees working for pharmaceutical companies can do a lot.
Under the federal False Claims Act, whistleblowers with inside information about adulterated or unsafe pharmaceutical products being sold in the United States are eligible for cash whistleblower rewards. The only big requirements are that you must have inside information and the drugs being sold in the United States are reimbursable by Medicare / Medicaid / or Tricare. (That is almost all prescription drugs.)
Another benefit of the False Claims Act is that you do not have to be a U.S. citizen or resident to collect a reward. While the case is being investigated by the government you can remain anonymous too.
Ready to learn more? We urge you to visit our Pharmaceutical Fraud Whistleblower and Adulterated Drug pages. Want to know if you have a case? Contact us for a completely confidential, no cost, no obligation review of your case. We can be reached by online, by email or by phone (direct).
Mahany Law – America’s Pharmaceutical Fraud / FDA Whistleblower Lawyers