FDA Cites Dr. Reddy Plant For Failing To Properly Test Solvents Linked To NDMA Contamination
Federal regulators have cited a Dr. Reddy’s plant in India for failing to do adequate testing, particularly on high levels of solvents detected in their drugs; which may be tied to the contamination of certain drugs by a dangerous carcinogen.
FDA investigators inspected the Dr. Reddy’s plaint in the Srikakulam District of India from January 20 to January 28, issuing a report that indicates the plant failed to adequately investigate out-of-specification results of commercial batches of active drug ingredients from December 2017 through December 2019, raising specific concerns about residual solvent tests.
Drug names and chemicals are redacted throughout the investigation, however, the FDA has placed a tighter focus on the use of solvents and cleaning those solvents off of machines following widespread valsartan recalls in 2018. The improper use of solvents is believed to have played a major role in the contamination of valsartan and similar generic drugs, which were found to contain high levels of N-nitrosodimethylamine (NDMA), and similar contaminants.
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The valsartan problems impacted most of the U.S. supply for that blood pressure medication, and it was discovered that changes in the generic drug manufacturing process may have resulted in the chemical byproduct contaminating drugs sold by several different companies. Following FDA investigations, additional recalls were also issued for losartan and irbesartan, which are part of the same class of medications, known as angiotensin receptor blockers (ARBs).
This new inspection report indicates the Dr. Reddy’s plant has “recurrent failures” for some residual solvents, but has not done a scientifically justified root cause analysis. The U.S. regulators note that the company’s investigations into the problem were inadequate, because they did not evaluate all of the potential root causes.
In addition, the company’s cleaning process for equipment have not been adequately established or validated, according to the report. A failure of this process could lead to high levels of solvents remaining on machines and contaminating drug products.
“During our review of the surface area of each equipment documented in the cleaning validation, we asked for the raw data for the surface calculations for each equipment,” the report notes. “According to the Team Member Process Engineer and Head Quality Assurance, there is no raw data for the surface area calculation for each manufacturing equipment. Because there is no raw data, there is no evidence that swab samples were actually analyzed.”
The same plant was one of three cited in a warning letter in 2015, and was the chief plant of concern because of the active ingredients sent to the U.S. At the time, FDA inspectors found that the company had a hidden testing laboratory in the facility, which contained records indicating the company secretly tested active pharmaceutical ingredients, hiding reports of batches that failed, and only reporting tests showing batches that passed.
A number of generic drug manufacturers now face valsartan lawsuits brought by individuals diagnosed with cancers after use of the contaminated pills. As lawyers continue to review and file claims over the coming months and years, it is widely expected that several thousand cases will be filed nationwide.
Given common questions of fact and law raised in the complaints, the federal cases has been centralized before U.S. District Judge Robert B. Kugler in the District of New Jersey, as part of an MDL, or multidistrict litigation.
As part of the coordinated pretrial proceedings, it is expected that Judge Kugler will eventually establish a “bellwether” process, where the parties will use the fact sheet information about each valsartan cancer claim to select a representative group cases, which will be prepared for early trial dates in the MDL.
While the outcome of these early “bellwether” trials will not be binding on other plaintiffs, they are typically scheduled in complex pharmaceutical litigation to help the parties gauge how juries may respond to evidence and testimony that will be repeated throughout the litigation, and facilitate potential valsartan cancer settlements with the manufacturers and distributors of the contaminated pills.
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