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Regulatory News | 15 March 2016 | By Zachary Brennan
The US Food and Drug Administration (FDA) has warned India-based Emcure Pharmaceuticals for repeated data manipulation and falsification.
The warning letter, issued 3 March, follows an inspection at the company’s Hinjwadi-based site from 27 January to 4 February. The site has been banned from shipping products to the US since July 2015.
Back in 2014, Emcure said it would hire a third-party auditor to conduct a comprehensive audit of all laboratory electronic and hard copy data after issues with data falsification and manipulation were uncovered.
Teva Pharmaceuticals, also in 2014, recalled more than 38,000 bottles of the anti-diabetic drug Glucovance (glyburide and metformin hydrochloride), the anti-inflammatory drug indomethacin and the hypertension drug methyldopa, all of which were manufactured by Emcure.
And this latest FDA inspection showed the company has not fared any better over time.
“Our 2015 inspection found continuing practices of data falsification and manipulation at your facility, indicating that previous corrections were ineffective,” FDA said. “Data falsification and manipulation, and your reliance on incomplete records to release product to the market, are repeat violations.”
A previous Emcure investigation confirmed that environmental monitoring samples were not collected and “the data was fraudulent,” FDA said, though the company did not demonstrate how it can ensure such records were reliable and accurate, or how the falsification of some of the reported data may have affected the quality of products.
FDA also raised questions about the firm’s aseptic processing techniques, sterilization practices and facility design.
The agency is now seeking a comprehensive evaluation of the extent of the inaccuracy of recorded and reported data, as well as a risk assessment of the potential effects of observed failures on the quality of drug products, including the effects of “deficient documentation and data management practices, aseptic processing breaches, and inadequate environmental monitoring program.”
In addition, FDA is requesting a new “management strategy for your firm that includes the details of your corrective action and preventive action plan. Describe the actions you will take, such as contacting your customers, recalling drugs, conducting additional testing and/or adding lots to your stability programs, or other steps to assure the quality of your drugs manufactured under the deficient conditions.”
Emcure did not respond to a request for comment.
But Emcure isn't alone in battling data falsification and integrity issues, which have been documented by FDA in other warning letters and Form 483s for Indian pharmaceutical companies over at least the last three years.
Tags: Emcure Pharmaceuticals, Indian drug company warning letters from FDA, warning letter