The US FDA has finally released the long-awaited 483 Warning Letter for the incredible cGMP violations found in a January-February 2015 inspection at Emcure’s Hinjawadi plant in Pune, Maharashtra India. The plant was quickly banned by FDA in March 2015 from importing any drugs into the USA. Of greatest concern, the Times of India has reported that Emcure is a manufacturing partner for some of the world’s largest Pharmaceutical companies: Pfizer, Novartis, Sanofi and Roche, who also supply America’s pharmacy shelves and our medicine cabinets.
See for yourself the FDA’s startling and lengthy Warning Letter dated March 3, 2016.
The FDA cited numerous, significant and ongoing violations of “Finished Pharmaceuticals”…drugs ready for shipment to the USA for commercial distribution and human consumption. The FDA revealed Emcure failed to comply with current Good Manufacturing Practices for methods or facility operations involved in the manufacturing, processing, packing, or holding of pharmaceuticals, rendering the products “adulterated” and in violation of US Food and Drug law.
Over the course of the year between the inspections and the March 2016 Warning Letter, Emcure responded to FDA’s observations of the many serious violations, and did not sufficiently correct the deficiencies under US law. The major and serious violations and inadequacies continued onward in time: lack of proper steps to prevent microbial contamination in products which were manufactured to be Aseptic (sterile, often for IV injection), poor sterilization techniques, facilities which lacked proper design to prevent contamination of drug products, unreliable monitoring of manufacturing personnel and visual inspection l including sterile operations.
Most egregious and alarmingly, FDA cites Emcure for its serious lack of adequate record keeping and even falsified and manipulated data and records for the sterile operations, methods and testing. Emcure continues to lack answers on how the records were falsified and how this will be prevented, by their own admission. This all goes back to the February 2014 and January-February 2015 inspections, and the continuing lack of complete cGMP compliance by Emcure. FDA stated in the Warning Letter: ”These violations posed a significant risk to the sterility of your products. FDA requests that you contact CDER's Drug Shortages Staff immediately, … so that we can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances in the manufacture of your drug.” The letter was signed by an FDA attorney who actually IS the Director of the Office of Manufacturing Compliance, the top official in the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
We note that the following Big Pharma/Emcure Partners products are currently listed on the FDA’s Drug Shortage List: Pfizer’s Tygacil® (tigecycline), Novartis’ Sandoz Division’s Aristospan® (triamcinolone hexacetonide Injectable Suspension), Pfizer’s (and Sandoz’ s generic version ) Zosyn® (piperacillin and tazobactam Injection), Pfizer’s Bicillin L-A® (penicillin G benzathine Injection), Pfzier’s Methylprednisolone Sodium Succinate for Injection, Sandoz’s L-Cysteine Hydrochloride Injection, Pfizer’s Adriamycin® (doxorubicin Injection), Pfizer’s Norpace® (disopyramide Phosphate Capsules), Sanofi’s Claforan® (cefotaxime Sodium Injection). See for yourself, and the manufacturing reasons cited for each shortage.
When will Emcure release the names of the drugs banned from US Importation as “redacted” in the FDA Warning Letter? When will we know which other Big Pharma’s prescription drug products will be on the Shortage List? Is there another, highly-ethical way of knowing the real story and trigger more immediate corrective actions for Big Pharma’s “Offshoring Tsunami” of America’s Prescription Drug Products?
If you or your colleagues, anywhere in the world, have evidence of significant cGMP deviations in the last 6 years for American-bound DS or DP, contact us confidentially by emailing us at: [hidden email] ….or call us in the US on +001-202-780-9957. We help match would-be whistleblowers with CM&C experts and qualified lawyers to ensure they receive the highest awards possible and protection from retaliation. There is no fee for our services. The Pharmaceutical Integrity Coalition (PIC) is an independent Advocacy Group, with no ties to the Pharma industry
The U.S. Department of Justice is authorized to pay whistleblowers – pharma workers and executives with inside knowledge of cGMP violations – an award of up to 30% of whatever the government collects from wrongdoers. We know that most pharma employees are hard-working, conscientious people that truly care about the industry and patient safety. We also know that receiving a large cash award potentially in the tens of millions of dollars is necessary to help those workers who do come forward to get a fresh start.
Our goals are simple: stop contaminated and questionable potency pharmaceuticals from entering the US commerce stream and reaching patients, and restore integrity to our profession and industry. We want to precipitate “the beginning of the end” of cGMP violations from manufacturing of America’s Pharmaceutical products anywhere in the world, and move to a future of sustained dependability and full trust in pharmaceuticals for health and healing. It’s all about why and how we grew our careers in the Pharma industry, to help people, and the only way we know how to practice our CM&C craft.